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510(k) K963851

TILTING RADIOGRAPHIC TABLE (REMOTE) by Acoma Medical Imaging, Inc. — Product Code IXR

K963851 is an FDA 510(k) premarket notification submitted by Acoma Medical Imaging, Inc. for the device "TILTING RADIOGRAPHIC TABLE (REMOTE)". The FDA issued a decision of Substantially Equivalent on January 23, 1997. The device falls under product code IXR (Table, Radiographic, Tilting), a Class II device regulated under 21 CFR 892.1980. Acoma Medical Imaging, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 1997
Date Received
September 25, 1996
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 Acoma Medical Imaging, Inc.

  • K981227 — SYMPHONY 360 REMOTE CONTROL TABLE (June 30, 1998)
  • K981131 — PATHFINDER MOBILE C ARM (June 26, 1998)
  • K944952 — ANGIOGRAPHIC SYSTEM (February 17, 1995)
  • K941017 — F/C/W TUBESTAND (July 29, 1994)
  • K941004 — CTS SYSTEM (July 29, 1994)
  • K925598 — BUCKYMATIC AUTOMATIC CHEST FILM CHANGER (February 1, 1993)
  • K921116 — PX-100 PORTABLE X-RAY GENERATOR (October 5, 1992)
  • K921425 — SCD-105 AND SCD-125 CAPACITOR DISCHARGE MOBILE X-R (August 27, 1992)
  • K902637 — FUTURUS 2001 X-RAY GENERATOR (August 3, 1990)
  • K900562 — TRANS X 100 CHEST FILM CHANGER (April 10, 1990)

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)
  • K961022 — TANGENT VI TABLE (May 3, 1996)
  • K954356 — COMPAX 90/15E (October 7, 1995)
  • K953556 — VACS TABLE, 9650 (September 26, 1995)
  • K953557 — SURGICAL C-ARM TABLE, 9610 (September 26, 1995)

FDA data resources