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FDA 510(k)

ATHENA-HF MAMMOGRAPHIC X-RAY SYSTEM

K-Number: K900989 · 1990-03-28

ApplicantFischer Imaging Corp.
Decision Date1990-03-28
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ATHENA-HF MAMMOGRAPHIC X-RAY SYSTEM 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 1990-03-28 under 510(k) number K900989. The device is classified under product code IZH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATHENA-HF MAMMOGRAPHIC X-RAY SYSTEM?

ATHENA-HF MAMMOGRAPHIC X-RAY SYSTEM is a medical device that received FDA 510(k) clearance on 1990-03-28. The listed applicant is Fischer Imaging Corp.. The 510(k) number is K900989.

When did ATHENA-HF MAMMOGRAPHIC X-RAY SYSTEM receive FDA 510(k) clearance?

ATHENA-HF MAMMOGRAPHIC X-RAY SYSTEM received FDA 510(k) clearance on 1990-03-28, under 510(k) number K900989.

Who is the listed applicant for ATHENA-HF MAMMOGRAPHIC X-RAY SYSTEM?

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 ATHENA-HF MAMMOGRAPHIC X-RAY SYSTEM?

The FDA product code for ATHENA-HF MAMMOGRAPHIC X-RAY SYSTEM is IZH.

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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: IZH)

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.

K203509SMART FINDERIms Giotto S.P.A.K202294Affirm Contrast BiopsyHologic, Inc.K191495Biopsy PositionerFujifilm CorporationK161575Affirm Lateral Arm Upright Biopsy AccessoryHologicK161920Comfort CoverPrecision Dynamics CorporationK153486Affirm Prone Biopsy SystemHologic, 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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