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)

5M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR ME511L (MDL2105A)

K-Number: K041737 · 2004-07-13

ApplicantTotoku Electric Co., Ltd.
Decision Date2004-07-13
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

5M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR ME511L (MDL2105A) is the device name listed in this FDA 510(k) record. The listed applicant is Totoku Electric Co., Ltd.. It received FDA 510(k) clearance on 2004-07-13 under 510(k) number K041737. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 5M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR ME511L (MDL2105A)?

5M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR ME511L (MDL2105A) is a medical device that received FDA 510(k) clearance on 2004-07-13. The listed applicant is Totoku Electric Co., Ltd.. The 510(k) number is K041737.

When did 5M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR ME511L (MDL2105A) receive FDA 510(k) clearance?

5M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR ME511L (MDL2105A) received FDA 510(k) clearance on 2004-07-13, under 510(k) number K041737.

Who is the listed applicant for 5M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR ME511L (MDL2105A)?

The FDA 510(k) record lists Totoku Electric Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 5M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR ME511L (MDL2105A)?

The FDA product code for 5M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR ME511L (MDL2105A) is LLZ.

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 Totoku Electric Co., Ltd. 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.

K11344321.3 INCH (54 CM) MONOCHROME LCD MONITOR MS23I2 (ML21023)K11313621.3INCH (54CM)COLOR LCD MONITOR CCL256I2(CL21256)K112145MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS33I2K11260421.3 INCH (54 CM) COLOR LCD MONITOR CCL356I2 (CL21356)K11149621.3 INCH (54CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITORK09272820.1 INCH (51 CM) COLOR LCD MONITOR CCL208 (CDL2013A)

View all 40 devices →

Related Devices (Code: LLZ)

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.

K261874Syneris PACS v.1.0.1.0SynerisK262442HipStudio AnalysisReplasia BVK261855Elucid PlaqueIQElucid Bioimaging, Inc.K254214OOOPDSTaiwan Main Orthopaedic Biotechnology Co., Ltd.K261861SPINEsim v1.0Mdsim S.A.K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC

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.

↑