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FDA 510(k)

MAMMOSPOT 3 AND MAMMOSPOT 8

K-Number: K904517 · 1990-11-15

ApplicantAmerican Mammographics, Inc.
Decision Date1990-11-15
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MAMMOSPOT 3 AND MAMMOSPOT 8 is the device name listed in this FDA 510(k) record. The listed applicant is American Mammographics, Inc.. It received FDA 510(k) clearance on 1990-11-15 under 510(k) number K904517. 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 MAMMOSPOT 3 AND MAMMOSPOT 8?

MAMMOSPOT 3 AND MAMMOSPOT 8 is a medical device that received FDA 510(k) clearance on 1990-11-15. The listed applicant is American Mammographics, Inc.. The 510(k) number is K904517.

When did MAMMOSPOT 3 AND MAMMOSPOT 8 receive FDA 510(k) clearance?

MAMMOSPOT 3 AND MAMMOSPOT 8 received FDA 510(k) clearance on 1990-11-15, under 510(k) number K904517.

Who is the listed applicant for MAMMOSPOT 3 AND MAMMOSPOT 8?

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

What is the FDA product code for MAMMOSPOT 3 AND MAMMOSPOT 8?

The FDA product code for MAMMOSPOT 3 AND MAMMOSPOT 8 is IZH.

Related Clinical Trials

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.

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Other records listing American Mammographics, Inc. 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.

K023229S.O.F.T. PADDLE (SPECIAL OPTIMIZED FULL COMPRESSION TRAY), MODEL SFT-PDLEK954521MAMMOSPOT PADDLEK903651AMI MAMMOSPOT

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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