510(k) K081858 ยท HKI Camera, Ophthalmic, Ac-Powered
RETCAM 3 OPHTHALMIC IMAGING SYSTEM
| Applicant | Clarity Medical Systems, Pleasanton CA, US |
| Decision | Substantially Equivalent, Nov 5, 2008 |
| Received | Jul 1, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081858
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 20, 2014 | Clarity Medical Systems Inc Halogen Lamp component in RetCam 3 System -
Clarity Medical Systems, Inc;
Pleasanton, CA.
General ophthalmic imaging including retinal, corneal and external imaging. Photo-documentation of pediatr Terminated |
HKI | None listed |
| Mar 7, 2014 | Clarity Medical Systems Inc RetCam 3, RetCam Portable and RetCam Shuttle;
manufactured by Clarity Medical Systems, Inc.; Pleasanton, CA 94588.
General ophthalmic imaging including retinal, corneal and external imaging. Terminated |
HKI | None listed |
| Feb 24, 2012 | Clarity Medical Systems Inc Retcam3 & Retcam Shuttle with version 6.0 software.
Clarity Medical Systems, Inc.
5775 W. Las Positas Blvd, Suite 200
Pleasanton, CA 94588
General ophthalmic imaging including retinal, corneal and e Terminated |
HKI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.