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510(k) K943581

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

K943581 is an FDA 510(k) premarket notification submitted by Mallinckrodt Group, Inc. for the device "HYDRADJUST IV UROLOGICAL TABLE". The FDA issued a decision of Substantially Equivalent on January 4, 1995. 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
January 4, 1995
Date Received
July 22, 1994
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)
  • 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)
  • 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