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FDA 510(k)

OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM

K-Number: K024012 · 2003-03-20

ApplicantGe Oec Medical Systems
Decision Date2003-03-20
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ge Oec Medical Systems. It received FDA 510(k) clearance on 2003-03-20 under 510(k) number K024012. 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 OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM?

OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 2003-03-20. The listed applicant is Ge Oec Medical Systems. The 510(k) number is K024012.

When did OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM receive FDA 510(k) clearance?

OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM received FDA 510(k) clearance on 2003-03-20, under 510(k) number K024012.

Who is the listed applicant for OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM?

The FDA 510(k) record lists Ge Oec Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM?

The FDA product code for OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM is JAA.

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Other records listing Ge Oec Medical Systems 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.

K073543OEC 9900 ELITEK0619539900 PLUS MOBILE FLUOROSCOPY SYSTEM WITH 3D AND NAVIGATION OPTIONSK052039GE OEC ALTITUDEK022069OEC FLUOROTRAK 9800 PLUSK021049OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEMK003837FLEXIVIEW 8800 DIGITAL MOBILE 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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