Atlas-Based Autosegmentation
FDA 510(k) K080799 · Computerized Medical Systems, Inc.
510(k) numberK080799
Submission
- Device name
- Atlas-Based Autosegmentation
- Applicant
- Computerized Medical Systems, Inc.
St. Louis, MO, US - Received
- March 21, 2008
- Decision date
- August 7, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K020027 | Focus Radiation Treatment Planning SystemMUJ · Traditional | 10/08/2002SE |
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Questions and answers
When was Atlas-Based Autosegmentation cleared by the FDA?
Atlas-Based Autosegmentation (K080799) received a 510(k) decision of Substantially Equivalent on August 7, 2008, 139 days after the submission was received.
What is the product code of K080799?
The FDA product code is LHN – System, Radiation Therapy, Charged-Particle, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.