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FDA 510(k)

ESP 3-PHASE X-RAY GENERATORS

K-Number: K884678 · 1989-01-17

ApplicantElscint, Inc.
Decision Date1989-01-17
Product CodeIZO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ESP 3-PHASE X-RAY GENERATORS is the device name listed in this FDA 510(k) record. The listed applicant is Elscint, Inc.. It received FDA 510(k) clearance on 1989-01-17 under 510(k) number K884678. 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 3-PHASE X-RAY GENERATORS?

ESP 3-PHASE X-RAY GENERATORS is a medical device that received FDA 510(k) clearance on 1989-01-17. The listed applicant is Elscint, Inc.. The 510(k) number is K884678.

When did ESP 3-PHASE X-RAY GENERATORS receive FDA 510(k) clearance?

ESP 3-PHASE X-RAY GENERATORS received FDA 510(k) clearance on 1989-01-17, under 510(k) number K884678.

Who is the listed applicant for ESP 3-PHASE X-RAY GENERATORS?

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

What is the FDA product code for ESP 3-PHASE X-RAY GENERATORS?

The FDA product code for ESP 3-PHASE X-RAY GENERATORS is IZO.

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Other records listing Elscint, Inc. as applicant

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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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