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FDA 510(k)

MAXIRAY 125 TUBE UNIT

K-Number: K781524 · 1978-10-17

ApplicantGeneral Electric Co.
Decision Date1978-10-17
Product CodeITY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MAXIRAY 125 TUBE UNIT is the device name listed in this FDA 510(k) record. The listed applicant is General Electric Co.. It received FDA 510(k) clearance on 1978-10-17 under 510(k) number K781524. The device is classified under product code ITY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAXIRAY 125 TUBE UNIT?

MAXIRAY 125 TUBE UNIT is a medical device that received FDA 510(k) clearance on 1978-10-17. The listed applicant is General Electric Co.. The 510(k) number is K781524.

When did MAXIRAY 125 TUBE UNIT receive FDA 510(k) clearance?

MAXIRAY 125 TUBE UNIT received FDA 510(k) clearance on 1978-10-17, under 510(k) number K781524.

Who is the listed applicant for MAXIRAY 125 TUBE UNIT?

The FDA 510(k) record lists General Electric Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAXIRAY 125 TUBE UNIT?

The FDA product code for MAXIRAY 125 TUBE UNIT is ITY.

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Other records listing General Electric Co. 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.

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Related Devices (Code: ITY)

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.

K000052X-RAY MONOBLOCK, MONOBLOCK XRS-60-330Dynarad Corp.K933162MRX-750Mrx Corp.K923094MOLYBDENUMSoutheastern Medical Diagnostics, Inc.K923141PHILIPS PRE-FILTER OPTIONPhilips Medical Systems, Inc.K921129MRX-700Mrx-Ray Tube Corp.K921130MRX-865Mrx-Ray Tube Corp.

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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