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510(k) K083029

MODEL R605DASM AUTOMATIC X-RAY COLLIMATOR by Ralco S.R.L. — Product Code IZW

K083029 is an FDA 510(k) premarket notification submitted by Ralco S.R.L. for the device "MODEL R605DASM AUTOMATIC X-RAY COLLIMATOR". The FDA issued a decision of Substantially Equivalent on December 5, 2008. The device falls under product code IZW (Collimator, Automatic, Radiographic), a Class II device regulated under 21 CFR 892.1610. Ralco S.R.L. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 2008
Date Received
October 10, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Ralco S.R.L.

  • K110856 — RALCO (August 10, 2011)
  • K091517 — RALCO, MODEL R225 ACS (July 14, 2009)
  • K072780 — MODEL R302DACS/A AUTOMATIC X-RAY COLLIMATOR (November 26, 2007)
  • K030487 — R 72 (August 1, 2003)
  • K946320 — R 302 (May 11, 1995)

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)
  • K072780 — MODEL R302DACS/A AUTOMATIC X-RAY COLLIMATOR (November 26, 2007)
  • K073124 — COLLIMARE COLLIMATOR FAMILY (November 16, 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