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510(k) K946320

R 302 by Ralco S.R.L. — Product Code KPW

K946320 is an FDA 510(k) premarket notification submitted by Ralco S.R.L. for the device "R 302". The FDA issued a decision of Substantially Equivalent on May 11, 1995. The device falls under product code KPW (Device, Beam Limiting, X-Ray, Diagnostic), 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
May 11, 1995
Date Received
December 28, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Beam Limiting, X-Ray, Diagnostic
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)
  • 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)

Other clearances for product code KPW

  • K093596 — LUMOS, MODEL R 72B (January 12, 2010)
  • K062788 — COLLIMATOR, MODEL M-38 (December 28, 2006)
  • K030487 — R 72 (August 1, 2003)
  • K954310 — BLA-800A (October 18, 1995)
  • K914184 — P2020-8-0 BEAM-LIMITING DEVICE (November 27, 1991)
  • K904587 — DENSICOMP 250 (January 24, 1991)
  • K904044 — TF-63SA (November 29, 1990)
  • K904489 — EUREKA EXTENSION CYLINDERS (October 15, 1990)
  • K820306 — RALCO COLLIMATOR, AUTOMATIC RADIOGRAPHIC (March 5, 1982)
  • K820305 — RALCO COLLIMATORS, MANUAL RADIOGRAPHIC (March 4, 1982)

FDA data resources