Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

AFFIRM BREAST BIOPSY GUIDANCE SYSTEM

K-Number: K122836 · 2013-01-11

ApplicantLorad, A Hologic Co.
Decision Date2013-01-11
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AFFIRM BREAST BIOPSY GUIDANCE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Lorad, A Hologic Co.. It received FDA 510(k) clearance on 2013-01-11 under 510(k) number K122836. 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 AFFIRM BREAST BIOPSY GUIDANCE SYSTEM?

AFFIRM BREAST BIOPSY GUIDANCE SYSTEM is a medical device that received FDA 510(k) clearance on 2013-01-11. The listed applicant is Lorad, A Hologic Co.. The 510(k) number is K122836.

When did AFFIRM BREAST BIOPSY GUIDANCE SYSTEM receive FDA 510(k) clearance?

AFFIRM BREAST BIOPSY GUIDANCE SYSTEM received FDA 510(k) clearance on 2013-01-11, under 510(k) number K122836.

Who is the listed applicant for AFFIRM BREAST BIOPSY GUIDANCE SYSTEM?

The FDA 510(k) record lists Lorad, A Hologic Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AFFIRM BREAST BIOPSY GUIDANCE SYSTEM?

The FDA product code for AFFIRM BREAST BIOPSY GUIDANCE SYSTEM 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 Lorad, A Hologic Co. 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.

K071542DIGITAL STEREOLOC IIK030666MULTICARE PLATINUM SYSTEM AND ACCESSORIESK013290MODIFIED 650 MAMMOGRAPHY SYSTEMK011987MODIFIED M-IV MAMMOGRAPHY SYSTEM

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.

↑