Diagnostic Medical Systems: FDA clearances and approvals
Diagnostic Medical Systems has 1 FDA 510(k) clearance (first 2000, latest 2000), plus 1 PMA decision, across 2 product codes in 1 review panel. Median 510(k) review time: 530 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 1 | 1 |
| MUA | Bone Sonometer | 1 | 0 |
Review panels
- Radiology (2)
Most recent Diagnostic Medical Systems 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K990517 | EXPLORER CVS TRANSCRANIAL DOPPLER | IYN | 2000-08-01 | 530 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P000055 | PMA | UBIS 5000 BONE SONOMETER | 2001-07-17 |
Recalls
openFDA lists no recalls under a recalling firm named Diagnostic Medical Systems.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Diagnostic Medical Systems have?
Diagnostic Medical Systems has 1 FDA 510(k) clearance (first 2000, latest 2000), plus 1 PMA decision, across 2 product codes in 1 review panel.
How long does FDA take to clear Diagnostic Medical Systems's 510(k)s?
The median time from FDA receipt to decision across Diagnostic Medical Systems's cleared 510(k)s is 530 days.
What devices does Diagnostic Medical Systems make?
Its most frequent FDA product codes are IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 1); MUA (Bone Sonometer, 1).
Has Diagnostic Medical Systems had device recalls?
openFDA lists no recalls under a recalling firm name matching Diagnostic Medical Systems. Related entities may recall under other names.
Next steps
- See all 1 Diagnostic Medical Systems clearances with predicates and recalls
- Run predicate analysis for product code IYN, Diagnostic Medical Systems's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.