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510(k) K933035

BCM-600TX by B C Medical , Ltd. — Product Code KPX

K933035 is an FDA 510(k) premarket notification submitted by B C Medical , Ltd. for the device "BCM-600TX". The FDA issued a decision of Substantially Equivalent on October 8, 1993. The device falls under product code KPX (Changer, Radiographic Film/Cassette), a Class II device regulated under 21 CFR 892.1860. B C Medical , Ltd. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 1993
Date Received
June 22, 1993
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 B C Medical , Ltd.

  • K946378 — BCM 400CP (May 4, 1995)
  • K933100 — ARC-600 (November 8, 1993)
  • K920862 — BCM-400C (September 30, 1992)
  • K890306 — BCM-ARC 105 X-RAY MOBILE UNIT (April 17, 1989)
  • K870205 — ROTAX-II BI-PLANE CIRCULAR ARM (March 6, 1987)
  • K801950 — BCM-600 MINI-SIX EXTRA LG. FIELD ANGIO (October 3, 1980)
  • K801949 — BCM-302 COLLIMATING CONE & COMPENSATIN (October 3, 1980)

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)
  • 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)
  • K902761 — AUTOMATIC CASSETTE LOADER (October 9, 1990)

FDA data resources