LUMISCAN 135 PHOSPHOR PLATE DIGITIZER/LUMISYS 135 ERASER— 510(k) K980809

Name: FDA 510(k) clearance K980809
Creator: U.S. Food and Drug Administration
Published: 1998-05-11

Substantially Equivalent

Lumisys, Inc.

FDA 510(k) clearance K980809 for LUMISCAN 135 PHOSPHOR PLATE DIGITIZER/LUMISYS 135 ERASER, Substantially Equivalent on 1998-05-11. Applicant: Lumisys, Inc.. Device class: 2.

Clearance details

Applicant: Lumisys, Inc.
Product code: Code LMA
Device class: Class 2
Regulation: 21 CFR 892.2030
Advisory panel: Radiology
Date received: 1998-03-03
Decision date: 1998-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Leandro, CA, US

Download summary PDF View on FDA.gov ↗

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