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FDA 510(k)

GE DISCOVERY IGS ANGIOGRAPHIC,FLUOROSCOPIC X-RAY SYSTEM

K-Number: K113403 · 2012-02-14

ApplicantGE Medical Systems SCS
Decision Date2012-02-14
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GE DISCOVERY IGS ANGIOGRAPHIC,FLUOROSCOPIC X-RAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems SCS. It received FDA 510(k) clearance on 2012-02-14 under 510(k) number K113403. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GE DISCOVERY IGS ANGIOGRAPHIC,FLUOROSCOPIC X-RAY SYSTEM?

GE DISCOVERY IGS ANGIOGRAPHIC,FLUOROSCOPIC X-RAY SYSTEM is a medical device that received FDA 510(k) clearance on 2012-02-14. The listed applicant is GE Medical Systems SCS. The 510(k) number is K113403.

When did GE DISCOVERY IGS ANGIOGRAPHIC,FLUOROSCOPIC X-RAY SYSTEM receive FDA 510(k) clearance?

GE DISCOVERY IGS ANGIOGRAPHIC,FLUOROSCOPIC X-RAY SYSTEM received FDA 510(k) clearance on 2012-02-14, under 510(k) number K113403.

Who is the listed applicant for GE DISCOVERY IGS ANGIOGRAPHIC,FLUOROSCOPIC X-RAY SYSTEM?

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

What is the FDA product code for GE DISCOVERY IGS ANGIOGRAPHIC,FLUOROSCOPIC X-RAY SYSTEM?

The FDA product code for GE DISCOVERY IGS ANGIOGRAPHIC,FLUOROSCOPIC X-RAY SYSTEM is OWB.

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Related Devices (Code: OWB)

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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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