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510(k) K781065

PLURIMAT;RADIOGRAPHIC TUBE MOUNT by Tecnomed, Inc. — Product Code IYB

K781065 is an FDA 510(k) premarket notification submitted by Tecnomed, Inc. for the device "PLURIMAT;RADIOGRAPHIC TUBE MOUNT". The FDA issued a decision of Substantially Equivalent on July 17, 1978. The device falls under product code IYB (Tube Mount, X-Ray, Diagnostic), a Class I device regulated under 21 CFR 892.1770. Tecnomed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 1978
Date Received
June 26, 1978
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 Tecnomed, Inc.

  • K892226 — TEC 6340 90/15 RADIOGRAPHIC/FLUOROSCOPIC TABLE (April 26, 1989)
  • K854203 — TEC 2720 MAMEX DC MAG (March 6, 1986)
  • K820307 — TECNOMED GENERATOR, RADIOGRAPH., 3 PHASE (March 5, 1982)
  • K827126 — TECHNOMED GENERATOR, RADIOGRAPHIC, 3 PHASE (March 5, 1982)
  • K820306 — RALCO COLLIMATOR, AUTOMATIC RADIOGRAPHIC (March 5, 1982)
  • K827124 — RALCO COLLIMATOR, AUTOMATIC, RADIOGRAPHIC (March 5, 1982)
  • K827125 — RALCO COLLIMATORS, MANUAL, RADIOGRAPHIC (March 4, 1982)
  • K820305 — RALCO COLLIMATORS, MANUAL RADIOGRAPHIC (March 4, 1982)
  • K811195 — ARGOSTAT (June 9, 1981)
  • K811196 — ALLMEC 90/15 (June 9, 1981)

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)
  • K941004 — CTS SYSTEM (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)

FDA data resources