RETCAM 3 OPHTHALMIC IMAGING SYSTEM— 510(k) K081858
Substantially EquivalentClarity Medical Systems
FDA 510(k) clearance K081858 for RETCAM 3 OPHTHALMIC IMAGING SYSTEM, Substantially Equivalent on 2008-11-05. 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
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pleasanton, CA, US
Recent devices under product code HKI
view allMore clearances from Clarity Medical Systems
view allRecalls naming K081858
K-number listed on FDA's recall record- 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.
- 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.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K081858.
Data sourced from openFDA. This site is unofficial and independent of the FDA.