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510(k) K950402

CORSINI 9090 by C.A.T. DI Corsini G. & C. Spa — Product Code IXR

K950402 is an FDA 510(k) premarket notification submitted by C.A.T. DI Corsini G. & C. Spa for the device "CORSINI 9090". The FDA issued a decision of Substantially Equivalent on March 31, 1995. The device falls under product code IXR (Table, Radiographic, Tilting), a Class II device regulated under 21 CFR 892.1980.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1995
Date Received
February 1, 1995
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 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)
  • K953557 — SURGICAL C-ARM TABLE, 9610 (September 26, 1995)

FDA data resources