Company ยท US
Clarity Medical Systems
FDA 510(k) clearances and medical device recalls filed under this name, 2008 to 2011. Name variants (Inc, Corp, punctuation) are merged.
4510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HKI | Camera, Ophthalmic, Ac-Powered | 7 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 20, 2011 | K102859 | RETCAM 3 OPTHALMIC IMAGING SYSTEM Clarity Medical Systems | HKI |
| Nov 25, 2009 | K090326 | RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMS Clarity Medical Systems | HKI |
| Jan 30, 2009 | K083771 | RETCAM PORTABLE OPHTHALMIC IMAGING SYSTEM, MODEL RCP Clarity Medical Systems | HKI |
| Nov 5, 2008 | K081858 | RETCAM 3 OPHTHALMIC IMAGING SYSTEM Clarity Medical Systems | HKI |
Latest recalls
| 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 | K081858 |
| 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 | K081858 K090326 +1 |
| 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 | K081858 K090326 +1 |