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510(k) K920742

HYDRAJUST IV UROLOGICAL TABLE by Mallinckrodt Group, Inc. — Product Code IXR

K920742 is an FDA 510(k) premarket notification submitted by Mallinckrodt Group, Inc. for the device "HYDRAJUST IV UROLOGICAL TABLE". The FDA issued a decision of Substantially Equivalent on April 27, 1992. The device falls under product code IXR (Table, Radiographic, Tilting), a Class II device regulated under 21 CFR 892.1980. Mallinckrodt Group, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 1992
Date Received
February 19, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Radiographic, Tilting
Device Class
Class II
Regulation Number
892.1980
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)
  • 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)
  • K904144 — PULMOVISION CHEST RADIOGRAPHY X-RAY SYSTEM (December 13, 1990)
  • K904145 — HYDRA VISION UROLOGICAL X-RAY SYSTEM (December 13, 1990)

Other clearances for product code IXR

  • K000412 — VISION R/F TILTING TABLE (April 24, 2000)
  • K973039 — LEGACY/LEGACY-D TABLE (October 16, 1997)
  • K971128 — CAP-35B III/CINE 275 (April 28, 1997)
  • K970640 — PHILIPS EASY DIAGNOST (March 21, 1997)
  • K965105 — ELECTROPHYSIOLOGY TILT TABLE MODEL #9660 (January 30, 1997)
  • K965096 — FLUOROVIEW SERIES FLUOROSCOPIC TABLES (January 27, 1997)
  • K963851 — TILTING RADIOGRAPHIC TABLE (REMOTE) (January 23, 1997)
  • K961022 — TANGENT VI TABLE (May 3, 1996)
  • K954356 — COMPAX 90/15E (October 7, 1995)
  • K953556 — VACS TABLE, 9650 (September 26, 1995)

FDA data resources