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FDA 510(k)

GEN-X 800/500

K-Number: K915227 · 1992-01-09

ApplicantSwiss Ray Medical Systems
Decision Date1992-01-09
Product CodeIZO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GEN-X 800/500 is the device name listed in this FDA 510(k) record. The listed applicant is Swiss Ray Medical Systems. It received FDA 510(k) clearance on 1992-01-09 under 510(k) number K915227. 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 GEN-X 800/500?

GEN-X 800/500 is a medical device that received FDA 510(k) clearance on 1992-01-09. The listed applicant is Swiss Ray Medical Systems. The 510(k) number is K915227.

When did GEN-X 800/500 receive FDA 510(k) clearance?

GEN-X 800/500 received FDA 510(k) clearance on 1992-01-09, under 510(k) number K915227.

Who is the listed applicant for GEN-X 800/500?

The FDA 510(k) record lists Swiss Ray Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GEN-X 800/500?

The FDA product code for GEN-X 800/500 is IZO.

Other records listing Swiss Ray Medical Systems 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.

K921539GEN-X 800/6/50K922813GEN-X 800-400 -- MODIFICATION

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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