TruSPECT Radiological Image Processing Station
FDA 510(k) K212230 · Spectrum Dynamics Medical, Ltd.
510(k) numberK212230
Submission
- Device name
- TruSPECT Radiological Image Processing Station
- Applicant
- Spectrum Dynamics Medical, Ltd.
Caesarea, IL - Received
- July 16, 2021
- Decision date
- August 16, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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More from Avara Software
| 510(k) | Device | Decision |
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| K254001 | VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400…KPS · Special | 01/13/2026SE |
| K253532 | TruSPECT Processing StationQIH · Special | 12/30/2025SE |
| K230600 | VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400…KPS · Abbreviated | 04/28/2023SE |
| K190457 | VERITON CT whole body SPECT/CT systemKPS · Traditional | 07/12/2019SE |
| K182484 | VERITON CT whole body SPECT/CT systemKPS · Abbreviated | 11/09/2018SE |
| K180514 | Veriton NMKPS · Traditional | 04/25/2018SE |
| K161740 | D-SPECT Scanner, D-SPECT L ScannerKPS · Traditional | 11/04/2016SE |
Questions and answers
When was TruSPECT Radiological Image Processing Station cleared by the FDA?
TruSPECT Radiological Image Processing Station (K212230) received a 510(k) decision of Substantially Equivalent on August 16, 2021, 31 days after the submission was received.
What is the product code of K212230?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.