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510(k) K854203

TEC 2720 MAMEX DC MAG by Tecnomed, Inc. — Product Code IZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 1986
Date Received
October 16, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Mammographic
Device Class
Class II
Regulation Number
892.1710
Review Panel
RA
Submission Type

Other clearances by Tecnomed, Inc.

  • K892226 — TEC 6340 90/15 RADIOGRAPHIC/FLUOROSCOPIC TABLE (April 26, 1989)
  • K827124 — RALCO COLLIMATOR, AUTOMATIC, RADIOGRAPHIC (March 5, 1982)
  • K827126 — TECHNOMED GENERATOR, RADIOGRAPHIC, 3 PHASE (March 5, 1982)
  • K820306 — RALCO COLLIMATOR, AUTOMATIC RADIOGRAPHIC (March 5, 1982)
  • K820307 — TECNOMED GENERATOR, RADIOGRAPH., 3 PHASE (March 5, 1982)
  • K827125 — RALCO COLLIMATORS, MANUAL, RADIOGRAPHIC (March 4, 1982)
  • K820305 — RALCO COLLIMATORS, MANUAL RADIOGRAPHIC (March 4, 1982)
  • K811196 — ALLMEC 90/15 (June 9, 1981)
  • K811197 — SUPERIX 120 (June 9, 1981)
  • K811195 — ARGOSTAT (June 9, 1981)

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  • K113607 — BIOPSY DIGIT S BIOPSY SL (August 10, 2012)