# Spectrum Dynamics Medical, Ltd.

- Location (FDA's records): Caesarea, IL
- FDA decisions: 8 (2016–2026): 8 510(k) clearances
- Product codes: KPS (6), LLZ (1), QIH (1)
- 510(k) review time since 2016: median 57 days, against 64 for FDA's reviews in the same codes and years (5 of 8 faster)
- Predicates its devices cite: 9 (6 its own); citations of its devices by later devices: 6 (6 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Spectrum Dynamics, Ltd.: 1 (https://510kreport.com/company/spectrum-dynamics)
- Spectrum Dynamics (Israel), Ltd.: 1 (https://510kreport.com/company/spectrum-dynamics-israel)
- GE Healthcare: 1 (https://510kreport.com/company/ge-healthcare)

## Its most-cited devices
- K212230: TruSPECT  Radiological Image Processing Station (2021), cited by 1
- K230600: VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464) (2023), cited by 1
- K161740: D-SPECT Scanner, D-SPECT L Scanner (2016), cited by 1
- K190457: VERITON CT whole body SPECT/CT system (2019), cited by 1
- K180514: Veriton NM (2018), cited by 1
- K182484: VERITON CT whole body SPECT/CT system (2018), cited by 1

## Recent decisions
- K254001: VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464) (Jan 13, 2026)
- K253532: TruSPECT Processing Station (Dec 30, 2025)
- K230600: VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464) (Apr 28, 2023)
- K212230: TruSPECT  Radiological Image Processing Station (Aug 16, 2021)
- K190457: VERITON CT whole body SPECT/CT system (Jul 12, 2019)
- K182484: VERITON CT whole body SPECT/CT system (Nov 9, 2018)
- K180514: Veriton NM (Apr 25, 2018)
- K161740: D-SPECT Scanner, D-SPECT L Scanner (Nov 4, 2016)

Source page: https://510kreport.com/company/spectrum-dynamics-medical