RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMS— 510(k) K090326

Name: FDA 510(k) clearance K090326
Creator: U.S. Food and Drug Administration
Published: 2009-11-25

Substantially Equivalent

Clarity Medical Systems

FDA 510(k) clearance K090326 for RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMS, Substantially Equivalent on 2009-11-25. Applicant: Clarity Medical Systems. Device class: 2.

Clearance details

Applicant: Clarity Medical Systems
Product code: Code HKI
Device class: Class 2
Regulation: 21 CFR 886.1120
Advisory panel: Ophthalmic
Date received: 2009-02-09
Decision date: 2009-11-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasanton, CA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K090326

K-number listed on FDA's recall record

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.Class II·Terminated·Clarity Medical Systems Inc·20140124

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K090326.

Data sourced from openFDA. This site is unofficial and independent of the FDA.