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FDA 510(k)

MAMMOSPOT PADDLE

K-Number: K954521 · 1995-10-24

ApplicantAmerican Mammographics, Inc.
Decision Date1995-10-24
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MAMMOSPOT PADDLE 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 1995-10-24 under 510(k) number K954521. 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 PADDLE?

MAMMOSPOT PADDLE is a medical device that received FDA 510(k) clearance on 1995-10-24. The listed applicant is American Mammographics, Inc.. The 510(k) number is K954521.

When did MAMMOSPOT PADDLE receive FDA 510(k) clearance?

MAMMOSPOT PADDLE received FDA 510(k) clearance on 1995-10-24, under 510(k) number K954521.

Who is the listed applicant for MAMMOSPOT PADDLE?

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 PADDLE?

The FDA product code for MAMMOSPOT PADDLE 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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-PDLEK903651AMI MAMMOSPOTK904517MAMMOSPOT 3 AND MAMMOSPOT 8

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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