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FDA 510(k)

HOFMANN G-S60 SINGLE PHASE X-RAY GENERATOR

K-Number: K851011 · 1985-04-10

ApplicantHofmann X-Ray of America, Inc.
Decision Date1985-04-10
Product CodeIZO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HOFMANN G-S60 SINGLE PHASE X-RAY GENERATOR is the device name listed in this FDA 510(k) record. The listed applicant is Hofmann X-Ray of America, Inc.. It received FDA 510(k) clearance on 1985-04-10 under 510(k) number K851011. 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 HOFMANN G-S60 SINGLE PHASE X-RAY GENERATOR?

HOFMANN G-S60 SINGLE PHASE X-RAY GENERATOR is a medical device that received FDA 510(k) clearance on 1985-04-10. The listed applicant is Hofmann X-Ray of America, Inc.. The 510(k) number is K851011.

When did HOFMANN G-S60 SINGLE PHASE X-RAY GENERATOR receive FDA 510(k) clearance?

HOFMANN G-S60 SINGLE PHASE X-RAY GENERATOR received FDA 510(k) clearance on 1985-04-10, under 510(k) number K851011.

Who is the listed applicant for HOFMANN G-S60 SINGLE PHASE X-RAY GENERATOR?

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

What is the FDA product code for HOFMANN G-S60 SINGLE PHASE X-RAY GENERATOR?

The FDA product code for HOFMANN G-S60 SINGLE PHASE X-RAY GENERATOR is IZO.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Hofmann X-Ray of America, 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.

K893690SUPER SPEED POTTER-BUCKY (ESO5-110 & 220)

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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