Spectrum Dynamics Medical, Ltd.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Spectrum Dynamics Medical, Ltd.” (first 2016, latest 2026), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 56 days. Since 2017 the median was 56 days, against 125 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 1 | 133 |
| 2017 | 0 | — |
| 2018 | 2 | 58 |
| 2019 | 1 | 137 |
| 2020 | 0 | — |
| 2021 | 1 | 31 |
| 2022 | 0 | — |
| 2023 | 1 | 56 |
| 2024 | 0 | — |
| 2025 | 1 | 47 |
| 2026 | 1 | 29 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Spectrum Dynamics Medical, Ltd. took a median 56 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 125 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KPS | System, Tomography, Computed, Emission | 6 | 6 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
| QIH | Automated Radiological Image Processing Software | 1 | 1 |
Review panels
- Radiology (8)
Most recent Spectrum Dynamics Medical, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| 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) | KPS | 2026-01-13 | 29 |
| K253532 | TruSPECT Processing Station | QIH | 2025-12-30 | 47 |
| 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 | 2023-04-28 | 56 |
| K212230 | TruSPECT Radiological Image Processing Station | LLZ | 2021-08-16 | 31 |
| K190457 | VERITON CT whole body SPECT/CT system | KPS | 2019-07-12 | 137 |
| K182484 | VERITON CT whole body SPECT/CT system | KPS | 2018-11-09 | 59 |
| K180514 | VERITON NM | KPS | 2018-04-25 | 57 |
| K161740 | D-SPECT Scanner, D-SPECT L Scanner | KPS | 2016-11-04 | 133 |
Recalls
openFDA lists no recalls under a recalling firm named Spectrum Dynamics Medical, Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Spectrum Designs, Inc. (18 510(k)s)
- Spectrum Medical , Ltd. (15 510(k)s)
- Spectrum X-Ray Corp. (9 510(k)s)
- Spectrum Spine, LLC (8 510(k)s)
- Spectrum Medical S.R.L. (6 510(k)s)
- Spectrum Vascular (6 510(k)s)
- Spectrum Co. (3 510(k)s)
- Spectrum Diagnostic, Inc. (3 510(k)s)
- Spectrum Dynamics , Ltd. (3 510(k)s)
- Spectrum Medical Technologies, Inc. (3 510(k)s)
- Spectrum Medical, Llp (2 510(k)s)
- Spectrum Antimicrobials, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Spectrum Dynamics Medical, Ltd.?
FDA lists 8 510(k) clearances under the applicant name “Spectrum Dynamics Medical, Ltd.” (first 2016, latest 2026), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Spectrum Dynamics Medical, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Spectrum Dynamics Medical, Ltd. is 56 days. Since 2017: 56 days, versus 125 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Spectrum Dynamics Medical, Ltd.?
The most frequent FDA product codes under this applicant name are KPS (System, Tomography, Computed, Emission, 6); LLZ (System, Image Processing, Radiological, 1); QIH (Automated Radiological Image Processing Software, 1).
Next steps
- See all 8 Spectrum Dynamics Medical, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code KPS, Spectrum Dynamics Medical, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.