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510(k) K896583

F.A.S.T. TABLE by Oec-Diasonics, Inc. — Product Code IXR

K896583 is an FDA 510(k) premarket notification submitted by Oec-Diasonics, Inc. for the device "F.A.S.T. TABLE". The FDA issued a decision of Substantially Equivalent on March 1, 1990. The device falls under product code IXR (Table, Radiographic, Tilting), a Class II device regulated under 21 CFR 892.1980. Oec-Diasonics, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1990
Date Received
November 21, 1989
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 Oec-Diasonics, Inc.

  • K926056 — 9600 FLUOROSCOPIC IMAGING SYSTEM (January 21, 1993)
  • K924879 — EP 3000 (January 4, 1993)
  • K914446 — UROVIEW 2000, MODIFICATION (January 10, 1992)
  • K893475 — UROVIEW II (August 10, 1989)
  • K872022 — UROVIEW (July 16, 1987)
  • K864837 — MODIFIED MAINFRAME OF MODEL 902 MOBILE C-ARM (January 30, 1987)
  • K843972 — ANGIOPLUS-S (January 3, 1985)

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