Data / Medical devices / United States / Spectrum Dynamics Medical Inc.
Spectrum Dynamics Medical Inc.: FDA-registered device maker in Sarasota, FL, United States, 6 510(k) clearances
Spectrum Dynamics Medical Inc. is registered with the FDA (registration 3008007310) in Sarasota, FL, United States. It lists 4 device types. The FDA files 6 510(k) clearances under its listings, the newest dated April 28, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008007310
- Address
- 301 N. Cattlemen Rd. Suite 109, Sarasota, FL, United States, 34232
- Owner or operator
- Spectrum Dynamics Medical, Inc. (10044466)
- Roles
- Complaint file establishment
- First device listed
- October 26, 2017
- Registered through
- 2026
- Brand names listed
- D-SPECT CARDIO, D-SPECT VISTA, TruSPECT, VERITON 200, VERITON CT 16, VERITON CT 216, VERITON CT 300 Series (VERITON CT 316/364) VERITON CT 400 Series (VERITON CT 316/416), VERITON CT 64, VERITON CT 264
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Complaint file establishment | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Complaint file establishment | accessdata.fda.gov |
| System, Tomography, Computed, Emission | KPS | 2 | Complaint file establishment | accessdata.fda.gov |
| System, X-Ray, Tomography, Computed | JAK | 2 | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 28, 2023 | 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) | KPS | Substantially Equivalent | Spectrum Dynamics Medical, Ltd. | accessdata.fda.gov |
| August 16, 2021 | K212230 | TruSPECT Radiological Image Processing Station | LLZ | Substantially Equivalent | Spectrum Dynamics Medical, Ltd. | accessdata.fda.gov |
| July 12, 2019 | K190457 | VERITON CT whole body SPECT/CT system | KPS | Substantially Equivalent | Spectrum Dynamics Medical, Ltd. | accessdata.fda.gov |
| November 9, 2018 | K182484 | VERITON CT whole body SPECT/CT system | KPS | Substantially Equivalent | Spectrum Dynamics Medical, Ltd. | accessdata.fda.gov |
| April 25, 2018 | K180514 | VERITON NM | KPS | Substantially Equivalent | Spectrum Dynamics Medical, Ltd. | accessdata.fda.gov |
| November 4, 2016 | K161740 | D-SPECT Scanner, D-SPECT L Scanner | KPS | Substantially Equivalent | Spectrum Dynamics Medical, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Tomography, Computed, Emission
- All makers of System, X-Ray, Tomography, Computed
- All makers of System, Image Processing, Radiological
- All makers of Automated Radiological Image Processing Software
Updated April 28, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.