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FDA 510(k)

ATHENA HFX

K-Number: K945619 · 1995-03-23

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

Device Summary

ATHENA HFX 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 K945619. 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 HFX?

ATHENA HFX 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 K945619.

When did ATHENA HFX receive FDA 510(k) clearance?

ATHENA HFX received FDA 510(k) clearance on 1995-03-23, under 510(k) number K945619.

Who is the listed applicant for ATHENA HFX?

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 HFX?

The FDA product code for ATHENA HFX 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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