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FDA 510(k)

BR 2002 X-RAY GENERATOR SYSTEM

K-Number: K801808 · 1980-09-26

ApplicantValmet Indus. Mach. & Prod., Inc.
Decision Date1980-09-26
Product CodeIZO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BR 2002 X-RAY GENERATOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Valmet Indus. Mach. & Prod., Inc.. It received FDA 510(k) clearance on 1980-09-26 under 510(k) number K801808. 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 BR 2002 X-RAY GENERATOR SYSTEM?

BR 2002 X-RAY GENERATOR SYSTEM is a medical device that received FDA 510(k) clearance on 1980-09-26. The listed applicant is Valmet Indus. Mach. & Prod., Inc.. The 510(k) number is K801808.

When did BR 2002 X-RAY GENERATOR SYSTEM receive FDA 510(k) clearance?

BR 2002 X-RAY GENERATOR SYSTEM received FDA 510(k) clearance on 1980-09-26, under 510(k) number K801808.

Who is the listed applicant for BR 2002 X-RAY GENERATOR SYSTEM?

The FDA 510(k) record lists Valmet Indus. Mach. & Prod., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BR 2002 X-RAY GENERATOR SYSTEM?

The FDA product code for BR 2002 X-RAY GENERATOR SYSTEM 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.

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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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