510(k) K032790
K032790 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions USA, Inc. for the device "MICROMLC". The FDA issued a decision of Substantially Equivalent on October 2, 2003. The device falls under product code IXI (Block, Beam-Shaping, Radiation Therapy), a Class II device regulated under 21 CFR 892.5710. Siemens Medical Solutions USA, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 2, 2003
- Date Received
- September 8, 2003
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Block, Beam-Shaping, Radiation Therapy
- Device Class
- Class II
- Regulation Number
- 892.5710
- Review Panel
- RA
- Submission Type