Home / 510(k) Clearances / K951372

510(k) K951372

PHILIPS GALLILEO AUTOMATIC COLLIMATOR (OR BEAM LIMITING DEVICE) by Philips Medical Systems, Inc. — Product Code IZW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 1995
Date Received
March 27, 1995
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 Philips Medical Systems, Inc.

  • K254186 — Azurion R3.1 (January 16, 2026)
  • K251827 — Azurion R3.1 (October 24, 2025)
  • K212704 — Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasoun (September 24, 2021)
  • K211597 — EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound (September 8, 2021)
  • K210560 — Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Car (June 30, 2021)
  • K191738 — PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardio (September 29, 2020)
  • K192875 — Philips Biosensor BX100 (April 16, 2020)
  • K183387 — M3290B Patient Information Center iX (August 6, 2019)
  • K180017 — MX40 Release C.01 (July 24, 2018)
  • K172226 — MX40 Release B.07 (November 9, 2017)

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)
  • 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)