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510(k) K924326

ARTHRODYN 45 DEGREE X-RAY TABLE by Arthrodyn, Inc. — Product Code IXR

K924326 is an FDA 510(k) premarket notification submitted by Arthrodyn, Inc. for the device "ARTHRODYN 45 DEGREE X-RAY TABLE". The FDA issued a decision of Substantially Equivalent on April 8, 1993. The device falls under product code IXR (Table, Radiographic, Tilting), a Class II device regulated under 21 CFR 892.1980. Arthrodyn, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 1993
Date Received
August 27, 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

Other clearances by Arthrodyn, Inc.

  • K925066 — PNEUMATIC IRRIGATION STANDARD (July 28, 1993)

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