CARA— 510(k) K110869

Substantially Equivalent

Diagnos, Inc.

FDA 510(k) clearance K110869 for CARA, Substantially Equivalent on 2011-07-14. Applicant: Diagnos, Inc.. Device class: 2.

Clearance details

Applicant: Diagnos, Inc.
Product code: Code NFJ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2011-03-29
Decision date: 2011-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Andover, MA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K110869

K-number listed on FDA's recall record

Z-0826-2022 — CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179Class II·Terminated·Diagnos Inc·20220111

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110869.

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