510(k) K042739
K042739 is an FDA 510(k) premarket notification submitted by Tomotherapy Incorporated for the device "HI-ART SYSTEM". The FDA issued a decision of Substantially Equivalent on November 3, 2004. The device falls under product code MUJ (System, Planning, Radiation Therapy Treatment), a Class II device regulated under 21 CFR 892.5050. Tomotherapy Incorporated has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 3, 2004
- Date Received
- October 4, 2004
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Planning, Radiation Therapy Treatment
- Device Class
- Class II
- Regulation Number
- 892.5050
- Review Panel
- RA
- Submission Type