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510(k) K810191

SIRCAM 103 by Siemens Corp. — Product Code IZJ

K810191 is an FDA 510(k) premarket notification submitted by Siemens Corp. for the device "SIRCAM 103". The FDA issued a decision of Substantially Equivalent on February 26, 1981. The device falls under product code IZJ (Camera, X-Ray, Fluorographic, Cine Or Spot), a Class II device regulated under 21 CFR 892.1620. Siemens Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 1981
Date Received
January 23, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, X-Ray, Fluorographic, Cine Or Spot
Device Class
Class II
Regulation Number
892.1620
Review Panel
RA
Submission Type

Other clearances by Siemens Corp.

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  • 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 IZJ

  • K024085 — CCD CAMERA, MODEL PKP-06000-000 (March 11, 2003)
  • K972130 — DISPOSABLE CAMERA COVER, ENCLOSED: DISPOSABLE CAMERA COVER, PERFORATED: DISPOSAB (October 9, 1997)
  • K945580 — DSP OPTION (January 30, 1995)
  • K920793 — PHILIPS DSI SYSTEM RELEASE 3.2 (July 17, 1992)
  • K896615 — CINE CAMERA CONTROL MODEL PK2037 (January 4, 1990)
  • K881688 — DTV-4114 FLUOROSCOPIC TELEVISION CAMERA (May 18, 1988)
  • K853983 — CANON X-RAY 35MM CINE CAMERA CSI-35 (October 16, 1985)
  • K812613 — VIDICAM 200 (December 8, 1981)
  • K810072 — 105MM ROLL FILM FLUOROGR. CAMERA, #105 (February 12, 1981)
  • K802132 — 105MM SPOT FILM CAMERA (October 23, 1980)

FDA data resources