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FDA 510(k)

THREE PHASE, DIAGNOSTIC X-RAY GENERATOR MICRO-X 80

K-Number: K880522 · 1988-05-04

ApplicantFischer Imaging Corp.
Decision Date1988-05-04
Product CodeIZO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

THREE PHASE, DIAGNOSTIC X-RAY GENERATOR MICRO-X 80 is the device name listed in this FDA 510(k) record. The listed applicant is Fischer Imaging Corp.. It received FDA 510(k) clearance on 1988-05-04 under 510(k) number K880522. 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 THREE PHASE, DIAGNOSTIC X-RAY GENERATOR MICRO-X 80?

THREE PHASE, DIAGNOSTIC X-RAY GENERATOR MICRO-X 80 is a medical device that received FDA 510(k) clearance on 1988-05-04. The listed applicant is Fischer Imaging Corp.. The 510(k) number is K880522.

When did THREE PHASE, DIAGNOSTIC X-RAY GENERATOR MICRO-X 80 receive FDA 510(k) clearance?

THREE PHASE, DIAGNOSTIC X-RAY GENERATOR MICRO-X 80 received FDA 510(k) clearance on 1988-05-04, under 510(k) number K880522.

Who is the listed applicant for THREE PHASE, DIAGNOSTIC X-RAY GENERATOR MICRO-X 80?

The FDA 510(k) record lists Fischer Imaging Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THREE PHASE, DIAGNOSTIC X-RAY GENERATOR MICRO-X 80?

The FDA product code for THREE PHASE, DIAGNOSTIC X-RAY GENERATOR MICRO-X 80 is IZO.

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Other records listing Fischer Imaging Corp. 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.

K042095MAMMOTESTK021113MAMMOPATHK981414LC POSITIONERK973400MAMMOTEST ADAPTER DRIVERK964806MD-1835K961207EP-X BIPLANE

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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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