KODAK DIRECTVIEW CR 800 SYSTEM, CATALOG# 1268622; KODAK DIRECTVIEW CR 900 SYSTEM, CATALOG# 1170976— 510(k) K020635

Name: FDA 510(k) clearance K020635
Creator: U.S. Food and Drug Administration
Published: 2002-03-21

Substantially Equivalent

Eastman Kodak Company

FDA 510(k) clearance K020635 for KODAK DIRECTVIEW CR 800 SYSTEM, CATALOG# 1268622; KODAK DIRECTVIEW CR 900 SYSTEM, CATALOG# 1170976, Substantially Equivalent on 2002-03-21. Applicant: Eastman Kodak Company. Device class: 2.

Clearance details

Applicant: Eastman Kodak Company
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2002-02-27
Decision date: 2002-03-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Rochester, NY, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K020635

K-number listed on FDA's recall record

Z-0820-2015 — CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for screening and diagnosis of breast cancer.Class II·Terminated·Carestream Health, Inc.·20141030

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K020635.

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