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510(k) K110856

RALCO by Ralco S.R.L. — Product Code IZX

K110856 is an FDA 510(k) premarket notification submitted by Ralco S.R.L. for the device "RALCO". The FDA issued a decision of Substantially Equivalent on August 10, 2011. The device falls under product code IZX (Collimator, Manual, 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
August 10, 2011
Date Received
March 28, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Ralco S.R.L.

  • 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)
  • K030487 — R 72 (August 1, 2003)
  • K946320 — R 302 (May 11, 1995)

Other clearances for product code IZX

  • K101036 — SHIMADZU COLLIMATOR R-20J (August 26, 2010)
  • K042840 — SHIMADZU COLLIMATOR R-20J (December 3, 2004)
  • K031771 — SHIMADZU COLLIMATOR R-30H (August 21, 2003)
  • K981267 — FACTS MONOBLOCK (May 6, 1998)
  • K974240 — LIGHTLINE-M (December 22, 1997)
  • K972966 — AXT 150M MANUAL COLLIMATOR (AXT 150M) (August 21, 1997)
  • K932134 — RINN UNIVERSAL COLLIMATOR (July 26, 1993)
  • K912180 — MODEL MGB-301 DIAPHRAGM FILM 24 X 30 CM (October 21, 1991)
  • K900007 — R-100-ET MANUAL COLLIMATOR (February 6, 1990)
  • K896486 — R-150-ET COLLIMATOR (January 23, 1990)

FDA data resources