AX-700LE AUTOMATIC X-RAY FILM PROCESSOR— 510(k) K925569

Name: FDA 510(k) clearance K925569
Creator: U.S. Food and Drug Administration
Published: 1993-01-15

Substantially Equivalent

Alphatek Corp.

FDA 510(k) clearance K925569 for AX-700LE AUTOMATIC X-RAY FILM PROCESSOR, Substantially Equivalent on 1993-01-15. Applicant: Alphatek Corp.. Device class: 2.

Clearance details

Applicant: Alphatek Corp.
Product code: Code IXW
Device class: Class 2
Regulation: 21 CFR 892.1900
Advisory panel: Radiology
Date received: 1992-11-03
Decision date: 1993-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

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