Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

GEN-X 800/650

K-Number: K914302 · 1991-10-30

ApplicantSwissray Finatech, Inc.
Decision Date1991-10-30
Product CodeIZO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GEN-X 800/650 is the device name listed in this FDA 510(k) record. The listed applicant is Swissray Finatech, Inc.. It received FDA 510(k) clearance on 1991-10-30 under 510(k) number K914302. 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 800/650?

GEN-X 800/650 is a medical device that received FDA 510(k) clearance on 1991-10-30. The listed applicant is Swissray Finatech, Inc.. The 510(k) number is K914302.

When did GEN-X 800/650 receive FDA 510(k) clearance?

GEN-X 800/650 received FDA 510(k) clearance on 1991-10-30, under 510(k) number K914302.

Who is the listed applicant for GEN-X 800/650?

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

What is the FDA product code for GEN-X 800/650?

The FDA product code for GEN-X 800/650 is IZO.

Other records listing Swissray Finatech, 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.

K915339GEN-X 800/300K914301GEN-X 800/800

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.

↑