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FDA 510(k)

DIGITAL 625HF

K-Number: K950291 · 1995-03-23

ApplicantFischer Imaging Corp.
Decision Date1995-03-23
Product CodeIZO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DIGITAL 625HF 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 1995-03-23 under 510(k) number K950291. 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 DIGITAL 625HF?

DIGITAL 625HF is a medical device that received FDA 510(k) clearance on 1995-03-23. The listed applicant is Fischer Imaging Corp.. The 510(k) number is K950291.

When did DIGITAL 625HF receive FDA 510(k) clearance?

DIGITAL 625HF received FDA 510(k) clearance on 1995-03-23, under 510(k) number K950291.

Who is the listed applicant for DIGITAL 625HF?

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 DIGITAL 625HF?

The FDA product code for DIGITAL 625HF 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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