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Spectrum Dynamics Medical, Ltd.

FDA 510(k) & PMA Approved Devices — 8 products

Total Devices8
Categories3
Latest FDA decision2026-01-13
TypeNumberDevice NameCodeDateActions
510(k) 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)KPS2026-01-13 View
510(k) K253532 TruSPECT Processing StationQIH2025-12-30 View
510(k) 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)KPS2023-04-28 View
510(k) K212230 TruSPECT Radiological Image Processing StationLLZ2021-08-16 View
510(k) K190457 VERITON CT whole body SPECT/CT systemKPS2019-07-12 View
510(k) K182484 VERITON CT whole body SPECT/CT systemKPS2018-11-09 View
510(k) K180514 VERITON NMKPS2018-04-25 View
510(k) K161740 D-SPECT Scanner, D-SPECT L ScannerKPS2016-11-04 View