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510(k) K833243

MAMMOGRAPHIC S-RAY SYSTEM by Xerox Medical Systems — Product Code IZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 1983
Date Received
August 18, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Mammographic
Device Class
Class II
Regulation Number
892.1710
Review Panel
RA
Submission Type

Other clearances by Xerox Medical Systems

  • K853459 — XERORADIOGRAPHY LIQUID TONER IMAGING SYSTEM (October 30, 1985)
  • K832733 — XEROX 120 SYS MAMMOGRAPHIC X-RAY (September 29, 1983)
  • K812024 — XEROX 128 CASSETTE CHANGER (August 13, 1981)
  • K791014 — DENTAL XERORADIOGRAPHY (September 4, 1979)

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