Clearance Summary
D-SPECT Processing and Reviewing Workstation received FDA 510(k) clearance under submission number K160120, sponsored by Spectrum Dynamics , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2016-03-21.
- Submission: K160120
- Applicant / Sponsor: Spectrum Dynamics , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1200
- Decision date: 2016-03-21
Classification & Regulation
This clearance is catalogued under FDA product code KPS and 21 CFR 892.1200, within the Radiology review panel as a Class II device.