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510(k) K832733

XEROX 120 SYS MAMMOGRAPHIC X-RAY by Xerox Medical Systems — Product Code IZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1983
Date Received
August 19, 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)
  • K833243 — MAMMOGRAPHIC S-RAY SYSTEM (October 28, 1983)
  • K812024 — XEROX 128 CASSETTE CHANGER (August 13, 1981)
  • K791014 — DENTAL XERORADIOGRAPHY (September 4, 1979)

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