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510(k) K792326

HILO TRANS-X TRAUMA TRANSPORT by Tecnomed, Inc. — Product Code IXR

K792326 is an FDA 510(k) premarket notification submitted by Tecnomed, Inc. for the device "HILO TRANS-X TRAUMA TRANSPORT". The FDA issued a decision of Substantially Equivalent on January 28, 1980. The device falls under product code IXR (Table, Radiographic, Tilting), a Class II device regulated under 21 CFR 892.1980. Tecnomed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 1980
Date Received
November 19, 1979
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 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 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