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FDA 510(k)

POLYDOROS XS50 AND SX80

K-Number: K923786 · 1992-12-17

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date1992-12-17
Product CodeIZO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

POLYDOROS XS50 AND SX80 is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 1992-12-17 under 510(k) number K923786. 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 POLYDOROS XS50 AND SX80?

POLYDOROS XS50 AND SX80 is a medical device that received FDA 510(k) clearance on 1992-12-17. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K923786.

When did POLYDOROS XS50 AND SX80 receive FDA 510(k) clearance?

POLYDOROS XS50 AND SX80 received FDA 510(k) clearance on 1992-12-17, under 510(k) number K923786.

Who is the listed applicant for POLYDOROS XS50 AND SX80?

The FDA 510(k) record lists Siemens Medical Solutions USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POLYDOROS XS50 AND SX80?

The FDA product code for POLYDOROS XS50 AND SX80 is IZO.

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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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