510(k) K212230
K212230 is an FDA 510(k) premarket notification submitted by Spectrum Dynamics Medical, Ltd. for the device "TruSPECT Radiological Image Processing Station". The FDA issued a decision of Substantially Equivalent on August 16, 2021. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Spectrum Dynamics Medical, Ltd. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 16, 2021
- Date Received
- July 16, 2021
- Clearance Type
- Special
- 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