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510(k) K781067

PLURIX B; RADIOGRAPHIC TABLE by Tecnomed, Inc. — Product Code IXQ

K781067 is an FDA 510(k) premarket notification submitted by Tecnomed, Inc. for the device "PLURIX B; RADIOGRAPHIC TABLE". The FDA issued a decision of Substantially Equivalent on July 17, 1978. The device falls under product code IXQ (Table, Radiographic, Stationary Top), 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
July 17, 1978
Date Received
June 26, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Radiographic, Stationary Top
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 IXQ

  • K973842 — CARBON FIBER CONFORMAL COUCH TOP (December 5, 1997)
  • K960083 — MOVABLE CANTILEVERED RADIOGRAPHIC TABLE XRT 100, 200 & 300 (July 24, 1996)
  • K954225 — MED-TEC HAND GRIP (November 14, 1995)
  • K946262 — EURO, SCST, SCCFT ATLAS RADIOLOGIC TABLES (February 15, 1995)
  • K942916 — OCTOPAQUE UNIVERSAL (September 8, 1994)
  • K942190 — ID100 MOBILE FLUOROSCOPIC EXAMINING TABLE (August 17, 1994)
  • K913425 — DIAL-A-RAD PORTA RAD TABLE (November 24, 1992)
  • K923775 — R-MADE HEAD/ARM SUPPORT (October 20, 1992)
  • K920729 — BUCKY TABLE BK-12 (April 27, 1992)
  • K914351 — CLINITRON C-10 (February 14, 1992)

FDA data resources