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510(k) K941004

CTS SYSTEM by Acoma Medical Imaging, Inc. — Product Code IYB

K941004 is an FDA 510(k) premarket notification submitted by Acoma Medical Imaging, Inc. for the device "CTS SYSTEM". The FDA issued a decision of Substantially Equivalent on July 29, 1994. The device falls under product code IYB (Tube Mount, X-Ray, Diagnostic), a Class I device regulated under 21 CFR 892.1770. Acoma Medical Imaging, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 1994
Date Received
March 1, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube Mount, X-Ray, Diagnostic
Device Class
Class I
Regulation Number
892.1770
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)
  • K963851 — TILTING RADIOGRAPHIC TABLE (REMOTE) (January 23, 1997)
  • K944952 — ANGIOGRAPHIC SYSTEM (February 17, 1995)
  • K941017 — F/C/W TUBESTAND (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 IYB

  • K935123 — SUPERSTAND 300 (March 27, 1996)
  • K946261 — MTS-007, STS-008, SSMTS-010, EURO-40, 72, SUPER EURO 4072, 5000 (February 15, 1995)
  • K941017 — F/C/W TUBESTAND (July 29, 1994)
  • K940442 — MPR-814 (June 9, 1994)
  • K935004 — MODEL ALPHA TS-2 (December 13, 1993)
  • K933253 — SUPERSTAND 3000 (August 16, 1993)
  • K925716 — BENNETT OVERHEAD TUBE CRANE MODEL NO. B-OTC (December 17, 1992)
  • K925170 — SHIMADZU X-RAY TUBE STAND BH-100 SERIES (December 7, 1992)
  • K920727 — CEILING TUBE SUPPORT CH-30X (April 16, 1992)
  • K914944 — BENNETT OVERHEAD TUBE CRANE MODEL NO. B-OTC (December 2, 1991)

FDA data resources