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510(k) K152303

CT Sim Laser System by Gammex, Inc. — Product Code IWE

K152303 is an FDA 510(k) premarket notification submitted by Gammex, Inc. for the device "CT Sim Laser System". The FDA issued a decision of Substantially Equivalent on September 11, 2015. The device falls under product code IWE (Monitor, Patient Position, Light-Beam), a Class I device regulated under 21 CFR 892.5780. Gammex, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 2015
Date Received
August 14, 2015
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 Gammex, Inc.

  • K954564 — PID-1 PRECISION INTELLIGENT DOSIMETER (April 22, 1996)
  • K953514 — COURIER II (October 7, 1995)

Other clearances for product code IWE

  • 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)
  • K935760 — TEC 2100 (MODEL MT-LPLGD) (January 25, 1994)

FDA data resources