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FDA 510(k)

EXPEDIO 500D R&F X-RAY SYSTEM

K-Number: K011624 · 2001-06-08

ApplicantGE Medical Systems
Decision Date2001-06-08
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EXPEDIO 500D R&F X-RAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems. It received FDA 510(k) clearance on 2001-06-08 under 510(k) number K011624. 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 EXPEDIO 500D R&F X-RAY SYSTEM?

EXPEDIO 500D R&F X-RAY SYSTEM is a medical device that received FDA 510(k) clearance on 2001-06-08. The listed applicant is GE Medical Systems. The 510(k) number is K011624.

When did EXPEDIO 500D R&F X-RAY SYSTEM receive FDA 510(k) clearance?

EXPEDIO 500D R&F X-RAY SYSTEM received FDA 510(k) clearance on 2001-06-08, under 510(k) number K011624.

Who is the listed applicant for EXPEDIO 500D R&F X-RAY SYSTEM?

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

What is the FDA product code for EXPEDIO 500D R&F X-RAY SYSTEM?

The FDA product code for EXPEDIO 500D R&F X-RAY SYSTEM is JAA.

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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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