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510(k) K832733

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

K832733 is an FDA 510(k) premarket notification submitted by Xerox Medical Systems for the device "XEROX 120 SYS MAMMOGRAPHIC X-RAY". The FDA issued a decision of Substantially Equivalent on September 29, 1983. The device falls under product code IZH (System, X-Ray, Mammographic), a Class II device regulated under 21 CFR 892.1710. Xerox Medical Systems has at least 4 other 510(k) clearances on record.

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)

Other clearances for product code IZH

  • K203509 — SMART FINDER (July 14, 2021)
  • K202294 — Affirm Contrast Biopsy (October 5, 2020)
  • K191495 — Biopsy Positioner (July 3, 2019)
  • K161575 — Affirm Lateral Arm Upright Biopsy Accessory (August 10, 2016)
  • K161920 — Comfort Cover (July 15, 2016)
  • K153486 — Affirm Prone Biopsy System (April 1, 2016)
  • K152038 — MammoGRIP (December 22, 2015)
  • K123414 — SPECBOARD JR. (January 11, 2013)
  • K122836 — AFFIRM BREAST BIOPSY GUIDANCE SYSTEM (January 11, 2013)
  • K113607 — BIOPSY DIGIT S BIOPSY SL (August 10, 2012)

FDA data resources