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510(k) K781984

COLLIMATOR, HEART CONTOUR by Siemens Corp. — Product Code KPW

K781984 is an FDA 510(k) premarket notification submitted by Siemens Corp. for the device "COLLIMATOR, HEART CONTOUR". The FDA issued a decision of Substantially Equivalent on December 4, 1978. The device falls under product code KPW (Device, Beam Limiting, X-Ray, Diagnostic), a Class II device regulated under 21 CFR 892.1610. Siemens Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 1978
Date Received
November 24, 1978
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 Siemens Corp.

  • K150843 — syngo®.via (version VB10A) (April 24, 2015)
  • K123375 — SYNGO.VIA (November 20, 2012)
  • K110366 — SYNGO.CT CARDIAC FUNCTION (April 12, 2011)
  • K103360 — DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL (December 17, 2010)
  • K081182 — MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST - INDUCIBL (August 8, 2008)
  • K071310 — SYNGO CT ONCOLOGY SOFTWARE PACKAGE (June 8, 2007)
  • K063507 — SYNGO NEURO PBV CT (November 30, 2006)
  • K063373 — FLEX LOOP COIL SET 3T (November 17, 2006)
  • K053024 — SYNGO NEURO DSA CT (November 4, 2005)
  • K050867 — SYNGO BODY PERFUSION-CT (April 14, 2005)

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)
  • K946320 — R 302 (May 11, 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)

FDA data resources