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510(k) K902761

AUTOMATIC CASSETTE LOADER by Mallinckrodt Group, Inc. — Product Code KPX

K902761 is an FDA 510(k) premarket notification submitted by Mallinckrodt Group, Inc. for the device "AUTOMATIC CASSETTE LOADER". The FDA issued a decision of Substantially Equivalent on October 9, 1990. The device falls under product code KPX (Changer, Radiographic Film/Cassette), a Class II device regulated under 21 CFR 892.1860. Mallinckrodt Group, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 1990
Date Received
June 25, 1990
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 Mallinckrodt Group, Inc.

  • K945053 — LF CT HIG PRESSURE CATHETERS (May 19, 1995)
  • K945140 — URO-FLO (March 8, 1995)
  • K943581 — HYDRADJUST IV UROLOGICAL TABLE (January 4, 1995)
  • K943122 — SURGICAL DRAPES (September 7, 1994)
  • K934664 — HYDRAGOWN (May 24, 1994)
  • K920742 — HYDRAJUST IV UROLOGICAL TABLE (April 27, 1992)
  • K912944 — CT 8000 DIGITAL INJECTION SYSTEM (February 4, 1992)
  • K913264 — HYDRAVIEW 1000 DIGITAL IMAGE PROCESS/STOR DEVICE (November 1, 1991)
  • K905789 — FRANKLIN 9000 WALL STAND (May 20, 1991)
  • K904145 — HYDRA VISION UROLOGICAL X-RAY SYSTEM (December 13, 1990)

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