Clarity Medical Systems
Country not established
- Devices
- 7
- FDA recalls
- 3
At a glance
Market reach
- United States
- FDA recalls
What Clarity Medical Systems makes
Clarity Medical Systems manufactures ophthalmic imaging systems designed for retinal photography and diagnostics, including portable and stationary models for clinical and surgical use. These devices capture high-resolution images of the retina, supporting applications such as diabetic retinopathy screening, retinal detachment monitoring, and intraoperative imaging. The portfolio includes standalone systems and accessories for enhanced portability and workflow integration.
The company’s ophthalmic imaging systems are classified as Class II medical devices under FDA regulations, with each model authorised via the 510(k) clearance pathway. These devices are listed in the FDA’s 510(k) database, reflecting their regulatory status in the United States. The company is headquartered in the US.
Catalogue
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Regimes: 510(k) Registry: 510(k)
Retcam 3 Ophthalmic Imaging System Ref K081858
Regimes: 510(k) Registry: 510(k)Retcam 3 Opthalmic Imaging System Ref K102859
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 3 recalls initiated by Clarity Medical Systems, the earliest on 2012-02-02 and the most recent on 2014-03-07. By recorded status: 3 terminated. The reasons filed fall into these groups: labeling or instructions for use, software or firmware, electrical or power and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2014
- 7 Mar 2014 Z-1265-2014 Class II Terminated 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.
Full distribution text
- 24 Jan 2014 Z-1154-2014 Class II Terminated 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.
Full distribution text
- 7 Mar 2014 Z-1265-2014 Class II Terminated 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.
2012
- 2 Feb 2012 Z-1099-2012 Not yet classified Terminated Still images extracted from video recordings may be mislabeled as to right and left eye.
Full distribution text
- 2 Feb 2012 Z-1099-2012 Not yet classified Terminated Still images extracted from video recordings may be mislabeled as to right and left eye.
Frequently asked questions
How many devices does Clarity Medical Systems have in the registry?
The registry currently lists 7 devices for Clarity Medical Systems. Devices recorded under merged duplicate company entries are counted once.
Which registries list Clarity Medical Systems's devices?
Among its 7 most recently registered devices, Clarity Medical Systems has devices listed in FDA 510(k) (4 devices) and FDA GUDID (3 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Clarity Medical Systems's devices fall under?
Among its 7 most recently registered devices, the classes recorded for Clarity Medical Systems's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Clarity Medical Systems?
FDA recall records list 3 recalls initiated by Clarity Medical Systems, the most recent initiated on 7 Mar 2014. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Clarity Medical Systems in the registry?
The most recently registered devices listed for Clarity Medical Systems include RetCam 3, RetCam Shuttle, RetCam Portable and RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMS.