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FDA 510(k)

XMA 325 (X-RAY GENERATOR)

K-Number: K850117 · 1985-04-09

ApplicantSummit Industries, Inc.
Decision Date1985-04-09
Product CodeIZO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

XMA 325 (X-RAY GENERATOR) is the device name listed in this FDA 510(k) record. The listed applicant is Summit Industries, Inc.. It received FDA 510(k) clearance on 1985-04-09 under 510(k) number K850117. 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 XMA 325 (X-RAY GENERATOR)?

XMA 325 (X-RAY GENERATOR) is a medical device that received FDA 510(k) clearance on 1985-04-09. The listed applicant is Summit Industries, Inc.. The 510(k) number is K850117.

When did XMA 325 (X-RAY GENERATOR) receive FDA 510(k) clearance?

XMA 325 (X-RAY GENERATOR) received FDA 510(k) clearance on 1985-04-09, under 510(k) number K850117.

Who is the listed applicant for XMA 325 (X-RAY GENERATOR)?

The FDA 510(k) record lists Summit Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XMA 325 (X-RAY GENERATOR)?

The FDA product code for XMA 325 (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 Summit Industries, 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.

K874908C900 X-RAY FILM PROCESSORK874687COLLI-MATETM MODEL NO. B800K851440RDIOGRAPHIC WALL HOLDER OR FILM RECEPTORK850198FLOOR TO WALL OR FLOOR TO CEILING TUBESTAND;RADIOGK850118XMA INTEGRATED TABLE

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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