Clarity Medical Systems
Pleasanton, CA, US
Clarity Medical Systems appears in FDA device records in Pleasanton, CA. FDA records list 4 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 3 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Clarity Medical Systems between 2008 and 2011. The busiest year on record is 2009, with 2. The most recent is 2011, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 1 |
| 2009 | 2 |
| 2011 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K102859 | RETCAM 3 OPTHALMIC IMAGING SYSTEM | HKI | Substantially Equivalent | |
| K090326 | RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMS | HKI | Substantially Equivalent | |
| K083771 | RETCAM PORTABLE OPHTHALMIC IMAGING SYSTEM, MODEL RCP | HKI | Substantially Equivalent | |
| K081858 | RETCAM 3 OPHTHALMIC IMAGING SYSTEM | HKI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1265-2014 | 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 pediatric ocular diseases including retinopathy of prematurity. Screening for Type-2 re-threshold retinopathy of prematurity or treatment requiring ROP. | One lot of Halogen lamps have the potential to fail sooner than the expected life of the lamp which could result in damage limited to the internal electrical components inside the RetCam 3 computer module. | Class II | Terminated | |
| Z-1154-2014 | 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. | Software anomaly for RetCam 3, RetCam Shuttle and RetCam Portable with software versions 6.0.x, 6.1. x and 6.2x where the patients age is calculated incorrectly. | Class II | Terminated | |
| Z-1099-2012 | 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 external imaging. Photodocumentation of pediatric ocular diseases including retinopathy or prematurity (ROP). Screening of Type-2 re-threshold retinopathy of prematurity or treatment requiring ROP. | Still images extracted from video recordings may be mislabeled as to right and left eye. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain