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)

DCM 1.0

K-Number: K011246 · 2001-05-23

ApplicantMds Nordion
Decision Date2001-05-23
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DCM 1.0 is the device name listed in this FDA 510(k) record. The listed applicant is Mds Nordion. It received FDA 510(k) clearance on 2001-05-23 under 510(k) number K011246. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DCM 1.0?

DCM 1.0 is a medical device that received FDA 510(k) clearance on 2001-05-23. The listed applicant is Mds Nordion. The 510(k) number is K011246.

When did DCM 1.0 receive FDA 510(k) clearance?

DCM 1.0 received FDA 510(k) clearance on 2001-05-23, under 510(k) number K011246.

Who is the listed applicant for DCM 1.0?

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

What is the FDA product code for DCM 1.0?

The FDA product code for DCM 1.0 is MUJ.

Other records listing Mds Nordion 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.

K060870AVANZAK051065RAYCELL X-RAY BLOOD IRRADIATORK050963GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELANK032684RAYCELLK010682HELAX-TMS V 5.1 RADIATION THERAPY TREATMENT PLANNING SYSTEMK001006THERATRON 780C/1000 WITH COMPUTERIZED CONSOLE UPGRADE

View all 7 devices →

Related Devices (Code: MUJ)

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.

K260750Virtual Cone (1.0)Varian Medical Systems, Inc.K253050RadOncAIInformaiK260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.K252784eXaSkin PlusAnatomical Geometry S.L.K253078ART.1-USSeetreat Pty, Ltd.K252304syngo.via RT Image Suite VC10Varian Medical Systems, 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.

↑