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510(k) K922591

UROLOGICAL C-ARM TABLE, MODEL #056-450 by Biodan Medical Systems, Ltd. — Product Code IXR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 1992
Date Received
June 2, 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

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  • K926083 — NUCLEAR PATIENT SANNING TABLES, VARIOUS TYPES (February 12, 1993)
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  • K922604 — DELUXE ADJUSTABLE HEIGHT ULTRASOUND TABLE (October 20, 1992)
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  • K923350 — CLOSED CHAIN ATTACHMENT, MODEL #820-520 (July 23, 1992)
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Other clearances for product code IXR

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  • 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)