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)

SECTRA MICRODOSE MAMMOGRAPHY

K-Number: K110025 · 2011-04-28

ApplicantSectra Imtec AB
Decision Date2011-04-28
Product CodeMUE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SECTRA MICRODOSE MAMMOGRAPHY is the device name listed in this FDA 510(k) record. The listed applicant is Sectra Imtec AB. It received FDA 510(k) clearance on 2011-04-28 under 510(k) number K110025. 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 SECTRA MICRODOSE MAMMOGRAPHY?

SECTRA MICRODOSE MAMMOGRAPHY is a medical device that received FDA 510(k) clearance on 2011-04-28. The listed applicant is Sectra Imtec AB. The 510(k) number is K110025.

When did SECTRA MICRODOSE MAMMOGRAPHY receive FDA 510(k) clearance?

SECTRA MICRODOSE MAMMOGRAPHY received FDA 510(k) clearance on 2011-04-28, under 510(k) number K110025.

Who is the listed applicant for SECTRA MICRODOSE MAMMOGRAPHY?

The FDA 510(k) record lists Sectra Imtec AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SECTRA MICRODOSE MAMMOGRAPHY?

The FDA product code for SECTRA MICRODOSE MAMMOGRAPHY 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 Sectra Imtec AB 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.

K081469SECTRA WORKSTATION, IDS7 VERSION 11.3, IDS5 VERSION 11.1 P2K063093SECTRA WORKSTATION, VERSION 11.1K051315MODIFICATION TO: SECTRA IDS5 WORKSTATIONK050196SECTRA IDS5 WORKSTATIONK040376SECTRA IDS5 RADIOLOGY WORKSTATION; SECTRA MPR PACKAGE; SECTRA 3D PACKAGEK033712MODIFICATION TO SECTRA IDS5 RADIOLOGY WORKSTATION - VERSION 10.1

View all 14 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.

↑