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510(k) K892226

TEC 6340 90/15 RADIOGRAPHIC/FLUOROSCOPIC TABLE by Tecnomed, Inc. — Product Code IXR

K892226 is an FDA 510(k) premarket notification submitted by Tecnomed, Inc. for the device "TEC 6340 90/15 RADIOGRAPHIC/FLUOROSCOPIC TABLE". The FDA issued a decision of Substantially Equivalent on Apr 26, 1989. The device falls under product code IXR (Table, Radiographic, Tilting), a Class II device regulated under 21 CFR 892.1980. Tecnomed, Inc. has 17 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Apr 26, 1989
Date Received
Apr 4, 1989
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
510(k) Exempt

Other clearances by Tecnomed, Inc.

  • K854203 — TEC 2720 MAMEX DC MAG (Mar 6, 1986)
  • K827124 — RALCO COLLIMATOR, AUTOMATIC, RADIOGRAPHIC (Mar 5, 1982)
  • K820307 — TECNOMED GENERATOR, RADIOGRAPH., 3 PHASE (Mar 5, 1982)
  • K827126 — TECHNOMED GENERATOR, RADIOGRAPHIC, 3 PHASE (Mar 5, 1982)
  • K820306 — RALCO COLLIMATOR, AUTOMATIC RADIOGRAPHIC (Mar 5, 1982)
  • K827125 — RALCO COLLIMATORS, MANUAL, RADIOGRAPHIC (Mar 4, 1982)
  • K820305 — RALCO COLLIMATORS, MANUAL RADIOGRAPHIC (Mar 4, 1982)
  • K811196 — ALLMEC 90/15 (Jun 9, 1981)
  • K811195 — ARGOSTAT (Jun 9, 1981)
  • K811197 — SUPERIX 120 (Jun 9, 1981)

Other clearances for product code IXR

  • K000412 — VISION R/F TILTING TABLE (Apr 24, 2000)
  • K973039 — LEGACY/LEGACY-D TABLE (Oct 16, 1997)
  • K971128 — CAP-35B III/CINE 275 (Apr 28, 1997)
  • K970640 — PHILIPS EASY DIAGNOST (Mar 21, 1997)
  • K965105 — ELECTROPHYSIOLOGY TILT TABLE MODEL #9660 (Jan 30, 1997)
  • K965096 — FLUOROVIEW SERIES FLUOROSCOPIC TABLES (Jan 27, 1997)
  • K963851 — TILTING RADIOGRAPHIC TABLE (REMOTE) (Jan 23, 1997)
  • K961022 — TANGENT VI TABLE (May 3, 1996)
  • K954356 — COMPAX 90/15E (Oct 7, 1995)
  • K953557 — SURGICAL C-ARM TABLE, 9610 (Sep 26, 1995)

FDA data resources

Source: FDA 510(k) database entry for K892226. Report a data issue: hello@regdatalab.com.