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510(k) K812217

FLUORO AUTOMATIC BRIGHTNESS SYS by Keystone X-Ray, Inc. — Product Code JAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1981
Date Received
August 5, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Fluoroscopic, Image-Intensified
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type

Other clearances by Keystone X-Ray, Inc.

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  • K883354 — VARIABLE KV INTREX VSK 60 - 90 KVP (December 21, 1988)

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