510(k) K183448
K183448 is an FDA 510(k) premarket notification submitted by Cefla S.C. for the device "NewTom 5G XL". The FDA issued a decision of Substantially Equivalent on March 8, 2019. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Cefla S.C. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 8, 2019
- Date Received
- December 12, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Tomography, Computed
- Device Class
- Class II
- Regulation Number
- 892.1750
- Review Panel
- RA
- Submission Type