Camera, Ophthalmic, Slit-Scanning
The Camera, Ophthalmic, Slit-Scanning is an AC-powered ophthalmic imaging device intended to take photographs of the eye and surrounding area using a slit-scanning mechanism for high-resolution imaging of ocular structures. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is eligible for third-party review, under regulation 886.1120 in the Ophthalmic specialty. The product code is QER. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QER
- Device Class
- FDA class 2
- Regulation Number
- 886.1120
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 1
Device Characteristics
Definition
An ophthalmic slit-scanning camera is an AC-powered device intended to take photographs of the eye and the surrounding area.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.