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FDA 510(k)

SIEMEN'S SIREMOBILE II C-ARM

K-Number: K902983 · 1990-11-06

ApplicantElectromek Diagnostic Systems, Inc.
Decision Date1990-11-06
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SIEMEN'S SIREMOBILE II C-ARM is the device name listed in this FDA 510(k) record. The listed applicant is Electromek Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1990-11-06 under 510(k) number K902983. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIEMEN'S SIREMOBILE II C-ARM?

SIEMEN'S SIREMOBILE II C-ARM is a medical device that received FDA 510(k) clearance on 1990-11-06. The listed applicant is Electromek Diagnostic Systems, Inc.. The 510(k) number is K902983.

When did SIEMEN'S SIREMOBILE II C-ARM receive FDA 510(k) clearance?

SIEMEN'S SIREMOBILE II C-ARM received FDA 510(k) clearance on 1990-11-06, under 510(k) number K902983.

Who is the listed applicant for SIEMEN'S SIREMOBILE II C-ARM?

The FDA 510(k) record lists Electromek Diagnostic Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIEMEN'S SIREMOBILE II C-ARM?

The FDA product code for SIEMEN'S SIREMOBILE II C-ARM is JAA.

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Other records listing Electromek Diagnostic Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K902986G.E. DXD 325/350/350II/DXD 525/525II GENERATORSK902987G.E. DXS 350/550/650/650II SINGLE PHASE GENERATORSK902988G.E. MSI 850/850II/1250 THREE PHASE GENERATORSK902985G.E. MST 625/625II/MST 1050/1050II THREE PHASE GENK902982G.E. POLARIX II C-ARMK902981G.E. FLUOROCON 300 IMAGING SYSTEM

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Related Devices (Code: JAA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253103Nexus DRF Digital X-ray Imaging SystemVarex Imaging CorporationK251650Insight Enhanced™ DRF (EN-1002-01)Imaging Engineering, LLCK242488Soteria E-ViewOmega Medical Imaging, LLCK242948Adora DRFi (04550010)Nrt X-Ray A/SK233380TRIDENT Mobile Fluoroscopy SystemDornier Medtech AmericaK233945ProxiDiagnost N90 / Precision CRF (706110, 706400)Philips Medical Systems Dmc GmbH

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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