Siemens Angiotron

FDA 510(k) K811587 · Siemens Corp.

Substantially Equivalent

510(k) numberK811587

Submission

Device name
Siemens Angiotron
Applicant
Siemens Corp.
Mchenry, IL, US
Received
June 5, 1981
Decision date
July 10, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
IXO – Synchronizer, Ecg / Respirator, Radiographic
Device class
Class I (low risk)
Regulation
21 CFR 892.1970
Specialty
Radiology

Other 510(k)s with product code IXO

510(k)DeviceApplicantDecision
K854976Rmi Respiratory Gating System Model 301IXO · Traditional Radiation Measurements, Inc.05/07/1986SE
K810588Synchronizer #208IXO · Traditional Brattle Instrument Corp.04/10/1981SE
K791959Post Extra Systolic PostentlatorIXO · Traditional Medrad, Inc.01/09/1980SE

More from Medrad, Inc.

510(k)DeviceDecision
K150843syngo®.via (version VB10A)LLZ · Abbreviated 04/24/2015SE
K123375Syngo.ViaLLZ · Traditional 11/20/2012SE
K110366Syngo.Ct Cardiac FunctionJAK · Traditional 04/12/2011SE
K103360Dimension Vista Digitoxin Calibrator - DGTX CalJIT · Traditional 12/17/2010SE
K081182Microscan Dried Gram-Positive Mic/Combo Panels New Antimicrobial Test - Inducible…JWY · Traditional 08/08/2008SE
K071310Syngo CT Oncology Software PackageJAK · Traditional 06/08/2007SE
K063507Syngo Neuro PBV CTJAK · Traditional 11/30/2006SE
K063373Flex Loop Coil Set 3TMOS · Traditional 11/17/2006SE
K053024Syngo Neuro Dsa CTJAK · Traditional 11/04/2005SE
K050867Syngo Body Perfusion-CtJAK · Traditional 04/14/2005SE

Questions and answers

When was Siemens Angiotron cleared by the FDA?

Siemens Angiotron (K811587) received a 510(k) decision of Substantially Equivalent on July 10, 1981, 35 days after the submission was received.

What is the product code of K811587?

The FDA product code is IXO – Synchronizer, Ecg / Respirator, Radiographic, a Class I (low risk) device regulated under 21 CFR 892.1970.