Clearance Summary
Implant Studio 2015 received FDA 510(k) clearance under submission number K152078, sponsored by 3Shape Medical A/S. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2015-12-04.
- Submission: K152078
- Applicant / Sponsor: 3Shape Medical A/S
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2015-12-04
Classification & Regulation
This clearance is catalogued under FDA product code LLZ and 21 CFR 892.2050, within the Radiology review panel as a Class II device.