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510(k) K973842

CARBON FIBER CONFORMAL COUCH TOP by Medtec, Inc. — Product Code IXQ

K973842 is an FDA 510(k) premarket notification submitted by Medtec, Inc. for the device "CARBON FIBER CONFORMAL COUCH TOP". The FDA issued a decision of Substantially Equivalent on December 5, 1997. The device falls under product code IXQ (Table, Radiographic, Stationary Top), a Class II device regulated under 21 CFR 892.1980. Medtec, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 1997
Date Received
October 8, 1997
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 Medtec, Inc.

  • K132908 — TRUPOINT ARCH, NASION CUSHION, BITE CUP, TRUPOINT ARCH STORAGE PLATE, TRUPOINT A (March 4, 2014)
  • K111340 — HEAD AND NECK IMMOBILIZATION SYSTEM, BODY IMMOBILIZATION SYSTEM (June 28, 2011)
  • K093738 — MRI PATIENT POSITIONING DEVICES (May 14, 2010)
  • K974703 — CARBON FIBER BREAST BOARD (March 10, 1998)
  • K974700 — MATRIX MT-MX3 (March 4, 1998)
  • K962622 — INTRA-ORAL THERMOPLASTIC SHIELD (October 1, 1996)
  • K955236 — GREEN TEC-2100 (May 24, 1996)
  • K954705 — ACRYSTEEL BLOCKING TRAY (January 5, 1996)
  • K954456 — THERMOPLASTIC SHIELD (December 21, 1995)
  • K954225 — MED-TEC HAND GRIP (November 14, 1995)

Other clearances for product code IXQ

  • 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)
  • K912382 — MILITARY RADIOGRAPHIC FLAT TABLE, CAT # T-9130 (October 10, 1991)

FDA data resources