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FDA 510(k)

X-RAY SYSTEM

K-Number: K780963 · 1978-06-27

ApplicantGeneral X-Ray, Inc.
Decision Date1978-06-27
Product CodeKPQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

X-RAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is General X-Ray, Inc.. It received FDA 510(k) clearance on 1978-06-27 under 510(k) number K780963. The device is classified under product code KPQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the X-RAY SYSTEM?

X-RAY SYSTEM is a medical device that received FDA 510(k) clearance on 1978-06-27. The listed applicant is General X-Ray, Inc.. The 510(k) number is K780963.

When did X-RAY SYSTEM receive FDA 510(k) clearance?

X-RAY SYSTEM received FDA 510(k) clearance on 1978-06-27, under 510(k) number K780963.

Who is the listed applicant for X-RAY SYSTEM?

The FDA 510(k) record lists General X-Ray, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for X-RAY SYSTEM?

The FDA product code for X-RAY SYSTEM is KPQ.

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Other records listing General X-Ray, 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.

K800998ATLAS-S X-RAY SYSTEM W/KETROMAT GEN.K790451X-RAY UNITS, GX-101, UCIS-510 AND GX-111K790392510 CARBINETTE X-RAY UNITK790393PORTABLE X-RAY UNIT, MATRIX S GX-101K790443PORTABLE X-RAY UNITK790511MOBILE X-RAY UNIT

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Related Devices (Code: KPQ)

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.

K132045ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONSGe Hungary KftK101038RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGERAcceletronics Digital Imaging, LLCK090706ONCENTRA SIMULATION 2.3Nucletron CorporationK083591IKOENGELO, VERSION 2Ikoetech, LLCK072445INTEGRATED BRACHYTHERAPY UNIT - DIGITALNucletron Corp.K061006IKOENGELOIkoetech, LLC

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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