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FDA 510(k)

GENDEX PRINCE 30 MEDICAL X-RAY GENERATOR

K-Number: K854499 · 1986-04-22

ApplicantGendex Corp.
Decision Date1986-04-22
Product CodeIZO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GENDEX PRINCE 30 MEDICAL X-RAY GENERATOR is the device name listed in this FDA 510(k) record. The listed applicant is Gendex Corp.. It received FDA 510(k) clearance on 1986-04-22 under 510(k) number K854499. The device is classified under product code IZO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENDEX PRINCE 30 MEDICAL X-RAY GENERATOR?

GENDEX PRINCE 30 MEDICAL X-RAY GENERATOR is a medical device that received FDA 510(k) clearance on 1986-04-22. The listed applicant is Gendex Corp.. The 510(k) number is K854499.

When did GENDEX PRINCE 30 MEDICAL X-RAY GENERATOR receive FDA 510(k) clearance?

GENDEX PRINCE 30 MEDICAL X-RAY GENERATOR received FDA 510(k) clearance on 1986-04-22, under 510(k) number K854499.

Who is the listed applicant for GENDEX PRINCE 30 MEDICAL X-RAY GENERATOR?

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

What is the FDA product code for GENDEX PRINCE 30 MEDICAL X-RAY GENERATOR?

The FDA product code for GENDEX PRINCE 30 MEDICAL X-RAY GENERATOR is IZO.

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Other records listing Gendex Corp. 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.

K952598GX-PAN PANORAMIC DENTAL X-RAY SYSTEMK945682PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTALK935046GX-770 X-RAY CONTROL, MODEL 46-404600G4K925094VISUALIX RADIOGRAPHIC IMAGE DETECTING AND PROCESSK931001ORALIX DCK932675GXP DENTAL X-RAY PROCESSOR

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Related Devices (Code: IZO)

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.

K954666MPH50, MPH65, AND MPH80GE Medical SystemsK953582HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATORVarian Canada, Inc.K953831N 800 HFNucletron-Oldelft Corp.K952822SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150GShimadzu Corp.K952265MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X-RAY GENERATORControl-X, Inc.K950883POLYDOROS SX 65 AND 80Siemens Medical Solutions USA, Inc.

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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