DCM 1.0
FDA 510(k) K011246 · Mds Nordion
510(k) numberK011246
Submission
- Device name
- DCM 1.0
- Applicant
- Mds Nordion
Ottawa, CA - Received
- April 23, 2001
- Decision date
- May 23, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code MUJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260750 | Virtual Cone (1.0)MUJ · Traditional | Varian Medical Systems, Inc. | 07/08/2026SE |
| K253050 | RadOncAIMUJ · Traditional | Informai | 06/18/2026SE |
| K260207 | Multimodality Simulation Workspace (MM Sim) (v1.0.0)MUJ · Traditional | Philips Medical Systems Nederland B.V. | 05/27/2026SE |
| K252784 | eXaSkin PlusMUJ · Traditional | Anatomical Geometry S.L. | 05/22/2026SE |
| K253078 | ART.1-USMUJ · Traditional | Seetreat Pty, Ltd. | 05/14/2026SE |
| K252304 | syngo.via RT Image Suite VC10MUJ · Traditional | Varian Medical Systems, Inc. | 03/18/2026SE |
| K260308 | TrueFit BolusMUJ · Special | Adaptiiv Medical Technologies, Inc. | 02/19/2026SE |
| K252002 | Monaco RTP System (6.3)MUJ · Traditional | Elekta Solutions AB | 02/19/2026SE |
| K253091 | ART-Plan+ (v3.1.0)MUJ · Traditional | Therapanacea Sas | 12/23/2025SE |
| K252109 | RayStation (2024A SP3)MUJ · Traditional | RaySearch Laboratories AB (PUBL) | 12/22/2025SE |
More from RaySearch Laboratories AB (PUBL)
| 510(k) | Device | Decision |
|---|---|---|
| K060870 | AvanzaJAI · Traditional | 05/15/2006SE |
| K053485 | Theratron Equinox, Models 80 CM and 100 CMIWB · Special | 03/09/2006SE |
| K051065 | Raycell X-Ray Blood IrradiatorMOT · Special | 05/26/2005SE |
| K050963 | Gammacell 1000 Elite and Gammacell 3000 ElanMOT · Special | 05/20/2005SE |
| K032684 | RaycellMOT · Special | 09/26/2003SE |
| K020971 | DCM 2.0MUJ · Traditional | 06/06/2002SE |
| K010682 | Helax-Tms V 5.1 Radiation Therapy Treatment Planning SystemMUJ · Traditional | 06/05/2001SE |
| K001006 | Theratron 780C/1000 with Computerized Console UpgradeIWB · Special | 04/27/2000SE |
Questions and answers
When was DCM 1.0 cleared by the FDA?
DCM 1.0 (K011246) received a 510(k) decision of Substantially Equivalent on May 23, 2001, 30 days after the submission was received.
What is the product code of K011246?
The FDA product code is MUJ – System, Planning, Radiation Therapy Treatment, a Class II (moderate risk) device regulated under 21 CFR 892.5050.