Quick facts
- United States: a retinal or fundus camera is a named device entry — 21 CFR 886.1120, ophthalmic camera — and sits in Class II.
- United States: the entry carries more than one product code, including an AC-powered ophthalmic camera (HKI) and a generic ophthalmic camera (PJZ), both Class II.
- Canada: there is no named ophthalmic-camera entry; the camera is classified by rule, and Rule 10(1) places an active diagnostic device that supplies energy for imaging or monitoring physiological processes in Class II.
- Canada: the same camera can move up only where an erroneous reading could cause immediate danger, which Rule 10(2) treats as Class III.
- Both countries: the camera captures the image; the swab, the paper and the chin-rest barrier that keep it clean are a separate purchase line.
- Canada: the regulation text cited here is current to 2026-09-21 and was last amended on 2026-06-17.
A retinal image looks the same whichever side of the border the camera sits on, but the two systems behind that camera do not read it the same way. One system files the instrument under a number of its own; the other decides a class from a rule about what the instrument does. For a clinic buyer, that split decides what a purchase order has to say, what the maintenance record has to carry, and what a reviewer will ask for when the instrument is checked.
What makes an ophthalmic camera a regulated device?
The camera is regulated because it images the inside of the eye for a clinical purpose, and both countries treat an instrument that does that as a medical device rather than as general optics.
The split is in how the instrument is described. In the United States the device is named directly: 21 CFR 886.1120 describes an ophthalmic camera as a device intended to photograph the eye. In Canada the same instrument is not named at all in the classification schedule that is attached to the Medical Devices Regulations, SOR/98-282; its class comes from the active-device rules instead.
That difference is not cosmetic. A named entry in the United States carries a code that a registration and a listing are filed against, and the code is what a buyer checks when a quotation is drawn up. A rule-based class in Canada carries no code — it carries the reason, and the reason is what a records review reads.
| Item | Canada | United States |
|---|---|---|
| How the camera is described | By rule, not by name | A named entry at 21 CFR 886.1120 |
| Class the instrument lands in | Class II under Rule 10(1) | Class II |
| What a filing cites | The rule and its subrule | The device entry and product code |
| What an upgrade in class needs | An erroneous reading that could cause immediate danger (Rule 10(2)) | A change that leaves the entry |
How does a rule-based class differ between Canada and the United States?
The American route asks what the device is called; the Canadian route asks what the device does. The two questions reach a similar class for a plain retinal camera and then part company as soon as the camera is aimed at a specific job.
Rule 10(1) in Canada covers an active diagnostic device that supplies energy for the purpose of imaging or monitoring physiological processes. A fundus camera supplies light and captures the reflected image, which places it squarely inside that subrule and in Class II. Rule 10(2) then lifts the class to Class III for a device intended to monitor, assess or diagnose a disease where an erroneous reading could result in immediate danger.
In the United States the 21 CFR 886.1120 entry does not carry that escalation inside it. A camera that matches the description is Class II, and a camera that has been changed so that it no longer matches would be assessed against a different path rather than against a subrule in the same section.
The practical reading for a clinic is that the Canadian class is a statement about use, while the American class is a statement about identity. A screening camera and a general-purpose camera can share one American entry and split across two Canadian subrules.
Is a retinal camera Class I or Class II in the United States?
It is Class II under the named entry, and the class does not turn on how the image is captured.
An ophthalmic camera in the American classification database is filed with the product codes HKI and PJZ among others, and both sit in Class II. The code distinguishes an AC-powered camera from a camera that is not described that way, but it does not move either one out of the class. An instrument using a handheld detector and an instrument sitting on a chin-rest stand are, for classification purposes, in the same class.
What this means for a clinic is that the phrase "it is only a camera" does not carry any weight in the United States. The device is regulated as an ophthalmic camera because that is the name it is given, and the class is fixed by that name.
| Camera type | US product code | US class | Canadian basis | Canadian class |
|---|---|---|---|---|
| AC-powered ophthalmic camera | HKI | Class II | Rule 10(1), active diagnostic imaging | Class II |
| Ophthalmic camera, not AC-powered | PJZ | Class II | Rule 10(1), active diagnostic imaging | Class II |
| Camera used where an error is immediately dangerous | Same entry | Class II | Rule 10(2), erroneous reading risk | Class III |
Does Canada name an ophthalmic camera, or does a rule decide its class?
A rule decides it. The Canadian schedule names a small number of devices outright — breast implants and tissue expanders sit in a table of their own — and leaves the rest to the rules that precede that table.
An ophthalmic camera is one of the devices the rules settle. Rule 10(1) reaches it because the camera is active and diagnostic and it supplies energy to image a physiological process. Rule 7, which catches other non-invasive devices, does not apply because an active device is dealt with by the active-device rules before the catch-all is reached.
The consequence is that a Canadian buyer cannot look the camera up by name and read off a class. The buyer has to know what the camera does, find the subrule that covers that description, and keep the subrule with the purchase record. When the same camera is bought for two different clinical uses, the class has to be re-read for each use rather than copied from the last order.
Does the class change in Canada and the United States for a screening programme?
It changes in Canada when the reading is one that could become immediately dangerous, and it stays put in the United States.
Retinal imaging used to screen for a condition where a missed finding leads to rapid harm is the situation Rule 10(2) was written for. The same camera that was Class II for a general examination becomes Class III when the intended use moves into that territory, because the risk of an erroneous reading is now part of the description. A programme that adds that use to an existing camera is changing the classification premise of the device, not only its workload.
In the United States, a screening camera remains inside the named ophthalmic-camera entry while it matches that description. A camera with a claimed use that falls outside the entry is assessed against whatever entry does describe it, which is a different mechanism from a subrule that escalates on risk.
For a clinic running both a general examination room and a screening list, the safe assumption is that the two uses should be recorded separately. The purchase record, the maintenance schedule and the operator log are easier to defend when the intended use is written next to the instrument rather than assumed.
Which consumables does an eye imaging room restock?
An imaging room runs on the same consumables as the rest of the practice, and the two closest to a camera are the paper and the swab. The exam table paper is changed between patients and covers the surface under the chin rest, while the double-tipped cotton swabs handle the wipe-down of the lens housing and the contact surfaces. A practice that also runs its own steriliser pairs the sterilization monitoring collection with the 24-hour monitoring five-pack trial. For clinics and multi-site groups buying at case level, the wholesale ordering page sets out account and case terms, and the B2B wholesale collection lists the lines held for institutional buyers. Reselling? become a distributor.
Sources
- 21 CFR 886.1120, ophthalmic camera
- 21 CFR 886.1150, visual acuity chart
- 21 CFR 886.1330, Amsler grid
- 21 CFR 886.1415, ophthalmic trial lens frame
- 21 CFR 886.1760, ophthalmic refractometer
- 21 CFR 886.1850, AC-powered slitlamp biomicroscope
- 21 CFR 886.4750, ophthalmic eye shield
- Medical Devices Regulations, SOR/98-282
- ISO 15004-1:2020, ophthalmic instruments
- ISO 13485:2016, medical device quality management
- ISO 14971:2019, risk management of medical devices
- IEC 61010-1:2010, safety of electrical measuring equipment
- openFDA device classification API
- American Academy of Ophthalmology, eye health
- American Academy of Ophthalmology, pink eye
- College of Optometrists of Ontario, standards of practice
- Opto, eye health library
- CCOHS, OSH answers
- Public Health Ontario, laboratory services test index
- CLSI, clinical and laboratory standards
An imaging room whose cleaning record is missing is a room that cannot answer a question about the last patient in the chair. The printable eye imaging room log is a free sheet with columns for the instrument, the wipe-down, the operator and the date, so a surface clean is written down rather than remembered. The log sheet generator sized to an imaging room builds the sheet from the number of rooms a practice runs and the instruments in each. No account and no sign-up are needed to open either one.
Ordering camera-room consumables for a clinic or a multi-site imaging group? See the wholesale ordering page.
Related reading
- Slit Lamps in Canada vs the US: Which Class
- Ophthalmic Refractometers in Canada vs the US: Which Class
- Visual Acuity Testing in Canada vs the US: Which Notation Applies
CliniEco Medical supplies laboratory, eye care and dental consumables of the kind described in this article. MDEL #35334. This article is written for optometry, laboratory and procurement professionals and is not legal advice; the class of an instrument and the records kept by a practice belong to the practice and to the requirements that apply to it.
Frequently Asked Questions
Is an ophthalmic camera a Class II device in the United States?
Yes. A device matching the ophthalmic camera entry at 21 CFR 886.1120 is in Class II, and that includes an AC-powered camera under product code HKI and a camera that is not described that way under code PJZ.
Does Canada have a named entry for an ophthalmic camera?
No. The Canadian schedule names very few devices outright, and an ophthalmic camera is not one of them. Its class is decided by the active-device rules, with Rule 10(1) placing an imaging or monitoring device in Class II.
When does an ophthalmic camera become Class III in Canada?
When the camera is intended to monitor, assess or diagnose a condition where an erroneous reading could cause immediate danger. Rule 10(2) escalates the class in that situation, so the intended use is part of the classification, not only the hardware.
What product code is used for an AC-powered ophthalmic camera?
The AC-powered ophthalmic camera is filed under product code HKI, and a camera that is not described as AC-powered is filed under PJZ. Both sit in Class II.
Why does the class differ when the camera is the same?
The American system names the device and fixes a class to that name. The Canadian system describes what the device does and fixes a class to that description, so the same hardware can take a different class when its intended use changes.
Is an imaging room log required for a camera?
A camera that does not touch the patient is not reprocessed, but the surfaces under and around it are cleaned between patients. Keeping the wipe-down, the operator and the date on one sheet is the record that answers a review, and it is written rather than recalled.
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