510(k) K152078
K152078 is an FDA 510(k) premarket notification submitted by 3Shape Medical A/S for the device "Implant Studio 2015". The FDA issued a decision of Substantially Equivalent on Dec 4, 2015. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. 3Shape Medical A/S has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 4, 2015
- Date Received
- Jul 27, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Image Processing, Radiological
- Device Class
- Class II
- Regulation Number
- 892.2050
- Review Panel
- RA
- Submission Type
- 510(k)