Home / 510(k) Clearances / K073124

510(k) K073124

COLLIMARE COLLIMATOR FAMILY by Collimare, LLC — Product Code IZW

K073124 is an FDA 510(k) premarket notification submitted by Collimare, LLC for the device "COLLIMARE COLLIMATOR FAMILY". The FDA issued a decision of Substantially Equivalent on November 16, 2007. The device falls under product code IZW (Collimator, Automatic, Radiographic), a Class II device regulated under 21 CFR 892.1610.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 2007
Date Received
November 6, 2007
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Collimator, Automatic, Radiographic
Device Class
Class II
Regulation Number
892.1610
Review Panel
RA
Submission Type

Other clearances for product code IZW

  • K101039 — SHIMADZU COLLIMATOR R-300 (September 20, 2010)
  • K093572 — R650 QDASM COLLIMATOR (February 3, 2010)
  • K090578 — SHIMADZU COLLIMATOR R-30H (November 6, 2009)
  • K091517 — RALCO, MODEL R225 ACS (July 14, 2009)
  • K083029 — MODEL R605DASM AUTOMATIC X-RAY COLLIMATOR (December 5, 2008)
  • K072780 — MODEL R302DACS/A AUTOMATIC X-RAY COLLIMATOR (November 26, 2007)
  • K050092 — R605 FACS COLLIMETER (January 31, 2005)
  • K031597 — DUNLEE FORMAT COLLIMATOR FAMILY (July 21, 2003)
  • K990423 — PHILIPS NICOL COLLIMATOR FAMILY (March 15, 1999)
  • K984414 — XRE COLLIMATOR WITH SPECTRAL FILTER (December 30, 1998)

FDA data resources