510(k) K013150
K013150 is an FDA 510(k) premarket notification submitted by Ultraguide , Ltd. for the device "MR-GUIDE 2000". The FDA issued a decision of Substantially Equivalent on October 18, 2001. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Ultraguide , Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 18, 2001
- Date Received
- September 20, 2001
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Nuclear Magnetic Resonance Imaging
- Device Class
- Class II
- Regulation Number
- 892.1000
- Review Panel
- RA
- Submission Type