Clearance Summary
IMPLANT STUDIO received FDA 510(k) clearance under submission number K141570, 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 2014-10-31.
- Submission: K141570
- Applicant / Sponsor: 3Shape Medical A/S
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2014-10-31
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.