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)

CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER

K-Number: K111324 · 2011-12-22

ApplicantAgfa Healthcare N.V.
Decision Date2011-12-22
Product CodeMUE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER is the device name listed in this FDA 510(k) record. The listed applicant is Agfa Healthcare N.V.. It received FDA 510(k) clearance on 2011-12-22 under 510(k) number K111324. The device is classified under product code MUE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER?

CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER is a medical device that received FDA 510(k) clearance on 2011-12-22. The listed applicant is Agfa Healthcare N.V.. The 510(k) number is K111324.

When did CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER receive FDA 510(k) clearance?

CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER received FDA 510(k) clearance on 2011-12-22, under 510(k) number K111324.

Who is the listed applicant for CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER?

The FDA 510(k) record lists Agfa Healthcare N.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER?

The FDA product code for CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER is MUE.

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 Agfa Healthcare N.V. 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.

K252199AGFA HealthCare Enterprise ImagingK180589DR 800 with MUSICA DynamicK172784DX-D Imaging PackageK170434Enterprise Imaging XERO Viewer 8.1K161368DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s)K161061IMPAX Volume Viewing 4.0

View all 19 devices →

Related Devices (Code: MUE)

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.

K254090I-View®Hologic, Inc.K253678MAMMOMAT B.brilliant (11372950)Siemens Medical Solutions USA, Inc.K254092Bellalun 2D (VDMS-1000S)Vieworks Co., Ltd.K260087Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena BrightGE Medical Systems SCSK243420HESTIAGenoray Co., Ltd.K2438492430TCA with Xmaru WRayence Co., Ltd.

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.

↑