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FDA 510(k)

ESP SERIES (X-RAY GENERATORS

K-Number: K820593 · 1982-03-19

ApplicantXonics Medical Systems, Inc.
Decision Date1982-03-19
Product CodeIZO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ESP SERIES (X-RAY GENERATORS is the device name listed in this FDA 510(k) record. The listed applicant is Xonics Medical Systems, Inc.. It received FDA 510(k) clearance on 1982-03-19 under 510(k) number K820593. 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 ESP SERIES (X-RAY GENERATORS?

ESP SERIES (X-RAY GENERATORS is a medical device that received FDA 510(k) clearance on 1982-03-19. The listed applicant is Xonics Medical Systems, Inc.. The 510(k) number is K820593.

When did ESP SERIES (X-RAY GENERATORS receive FDA 510(k) clearance?

ESP SERIES (X-RAY GENERATORS received FDA 510(k) clearance on 1982-03-19, under 510(k) number K820593.

Who is the listed applicant for ESP SERIES (X-RAY GENERATORS?

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

What is the FDA product code for ESP SERIES (X-RAY GENERATORS?

The FDA product code for ESP SERIES (X-RAY GENERATORS 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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Other records listing Xonics Medical Systems, 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.

K827292MODEL IC 3000K791298DIAGNOSTIC ULTRASOUND SYSTEMK770693X-RAY DEVICE, MAMMOGRAPHIC DIAGNOSTIC

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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