KODAK EKTASCAN— 510(k) K923554

Substantially Equivalent

Eastman Kodak Company

FDA 510(k) clearance K923554 for KODAK EKTASCAN, Substantially Equivalent on 1993-02-12. Applicant: Eastman Kodak Company. Device class: 2.

Clearance details

Applicant: Eastman Kodak Company
Product code: Code IXW
Device class: Class 2
Regulation: 21 CFR 892.1900
Advisory panel: Radiology
Date received: 1992-07-17
Decision date: 1993-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

Download summary PDF View on FDA.gov ↗

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More clearances from Eastman Kodak Company

K060550 — KODAK DIRECTVIEW DR 3000 SYSTEM 64KW/80KW GENERATORS, MODELS 6551345, 65513862006-03-31
K060137 — KODAK ECLIPSE IMAGE PROCESSING SOFTWARE2006-03-16
K060079 — KODAK MODEL CR-7400 DIGITAL RADIOGRAPHY SYSTEM2006-02-08
K060055 — KODAK PACS2006-02-07
K053347 — KODAK CARESTREAM PACS2006-01-04

Recalls naming K923554

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 K923554.

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