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510(k) K812024

XEROX 128 CASSETTE CHANGER by Xerox Medical Systems — Product Code KPX

K812024 is an FDA 510(k) premarket notification submitted by Xerox Medical Systems for the device "XEROX 128 CASSETTE CHANGER". The FDA issued a decision of Substantially Equivalent on August 13, 1981. The device falls under product code KPX (Changer, Radiographic Film/Cassette), a Class II device regulated under 21 CFR 892.1860. Xerox Medical Systems has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 1981
Date Received
July 20, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Changer, Radiographic Film/Cassette
Device Class
Class II
Regulation Number
892.1860
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)
  • K832733 — XEROX 120 SYS MAMMOGRAPHIC X-RAY (September 29, 1983)
  • K791014 — DENTAL XERORADIOGRAPHY (September 4, 1979)

Other clearances for product code KPX

  • K945635 — TRANS X-1000 (February 1, 1995)
  • K935157 — ARTICULATED, LAPAROSCOPIC, AND SIDE-VIEWING T-PROBES (August 9, 1994)
  • K934850 — NUCLEAR ASSOCIATES PERSONNEL PROTECTIVE SHIELDS (November 22, 1993)
  • K933035 — BCM-600TX (October 8, 1993)
  • K925598 — BUCKYMATIC AUTOMATIC CHEST FILM CHANGER (February 1, 1993)
  • K924423 — MWX-7440 HIGH SPEED BUCKY (January 15, 1993)
  • K925169 — SHIMADZU RADIOGRAPJHIC STAND BR-100 (December 3, 1992)
  • K920196 — OX-600 (October 14, 1992)
  • K922483 — DU PONT COMPACT DAYLIGHT SYSTEM 2000 (September 11, 1992)
  • K905789 — FRANKLIN 9000 WALL STAND (May 20, 1991)

FDA data resources