FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMS
K Number: K090326
·
Decision Nov 25, 2009
Classifications
1
FEI Numbers
65
Registration Numbers
66
Same Product Code
155
Applicant Total
4
Review Days
289
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMS
- K Number
- K090326
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1120
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Clarity Medical Systems
- Date Received
- February 9, 2009
- Decision Date
- November 25, 2009
- Product Code
- HKI
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HKI | Camera, Ophthalmic, Ac-Powered | FDA class 2 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HKI), ordered by most recent decision date.
Eyer 2
FDA 510(k)
FDA Class 2
·Ophthalmic
Fundus On Phone Non Mydriatic (FOP NM-10)
FDA 510(k)
FDA Class 2
·Ophthalmic
Optina-4C (MHRC-C1N)
FDA 510(k)
FDA Class 2
·Ophthalmic
3nethra neo HD FA; 3nethra neo HD
FDA 510(k)
FDA Class 2
·Ophthalmic
Resolve Fundus Camera
FDA 510(k)
FDA Class 2
·Ophthalmic
Sentinel Camera
FDA 510(k)
FDA Class 2
·Ophthalmic