510(k) K090173
K090173 is an FDA 510(k) premarket notification submitted by Neusoft Medical Systems Co., Ltd. for the device "NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM". The FDA issued a decision of Substantially Equivalent on February 5, 2009. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Neusoft Medical Systems Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 5, 2009
- Date Received
- January 23, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- System, X-Ray, Tomography, Computed
- Device Class
- Class II
- Regulation Number
- 892.1750
- Review Panel
- RA
- Submission Type