510(k) K011418
K011418 is an FDA 510(k) premarket notification submitted by Ultraguide , Ltd. for the device "ULTRAGUIDE MR-GUIDE 3000". The FDA issued a decision of Substantially Equivalent on May 24, 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
- May 24, 2001
- Date Received
- May 9, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- System, Nuclear Magnetic Resonance Imaging
- Device Class
- Class II
- Regulation Number
- 892.1000
- Review Panel
- RA
- Submission Type