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510(k) K934519

RADIATION EXIT VERIFICATION SYSTEM/BACK POINTER SYSTEM by Medtec, Inc. — Product Code IWE

K934519 is an FDA 510(k) premarket notification submitted by Medtec, Inc. for the device "RADIATION EXIT VERIFICATION SYSTEM/BACK POINTER SYSTEM". The FDA issued a decision of Substantially Equivalent on December 13, 1993. The device falls under product code IWE (Monitor, Patient Position, Light-Beam), a Class I device regulated under 21 CFR 892.5780. Medtec, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 1993
Date Received
September 17, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Patient Position, Light-Beam
Device Class
Class I
Regulation Number
892.5780
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)
  • K973842 — CARBON FIBER CONFORMAL COUCH TOP (December 5, 1997)
  • 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)

Other clearances for product code IWE

  • K152303 — CT Sim Laser System (September 11, 2015)
  • K973162 — DUAL RADIATION TARGETING SYSTEM DRTS DRAPE (November 20, 1997)
  • K955236 — GREEN TEC-2100 (May 24, 1996)
  • K954414 — CENTRALITE BACKPOINTER (October 23, 1995)
  • K950293 — TEC-2110 GREEN LASER MODEL MT-HNG (August 18, 1995)
  • K950112 — CENTRALITE(R)-DLL SERIES (August 16, 1995)
  • K951601 — MED-TEC STRING RETICLE TRAY (May 11, 1995)
  • K943802 — HP BACK POINTER SYSTEM (December 7, 1994)
  • K943381 — LASER ALIGNMENT TOOL (August 9, 1994)
  • K941169 — TEC 2101 (MODEL MT-HPLGD) (July 18, 1994)

FDA data resources