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510(k) K840227

UROLIX-3 UROLOGICAL TABLE by Medicor USA , Ltd. — Product Code IXR

K840227 is an FDA 510(k) premarket notification submitted by Medicor USA , Ltd. for the device "UROLIX-3 UROLOGICAL TABLE". The FDA issued a decision of Substantially Equivalent on March 23, 1984. The device falls under product code IXR (Table, Radiographic, Tilting), a Class II device regulated under 21 CFR 892.1980. Medicor USA , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 1984
Date Received
January 19, 1984
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 Medicor USA , Ltd.

  • K861994 — MODEL RS-3I RADIOGRAPHIC/FLUROSCOPIC X-RAY SYSTEM (July 18, 1986)
  • K861995 — MODEL RS-3 RADIOGRAPHIC STAND (June 19, 1986)
  • K860025 — MODEL MS-325 RADIOGRAPHIC X-RAY GENERATOR (May 7, 1986)
  • K850761 — MODEL PCX/EMY 525A MICROPROCESSSOR CONTROL X-RAY C (September 19, 1985)
  • K851358 — MODEL BION 2/TYPE 90 ROOM IONIZER (July 1, 1985)
  • K851094 — MODEL BION 1/TYPE 1084T CAR IONIZER (June 19, 1985)
  • K843335 — FLOOR MOUNTED X-RAY TUBESTAND (November 27, 1984)
  • K840225 — C-ARM CEILING CRANE FT-2 (March 22, 1984)
  • K840226 — MOTOR TILTED EXAM. TABLE UV-56 (March 16, 1984)
  • K823695 — CPM METABOLIC MONITOR (January 14, 1983)

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