Telescan Medical Systems: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Telescan Medical Systems” (first 1982, latest 1995), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 110 days. 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 4 | 4 |
| DSH | Recorder, Magnetic Tape, Medical | 1 | 1 |
Review panels
- Cardiovascular (5)
Most recent Telescan Medical Systems 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K942586 | CARDIAC EVENT RECORDER (INSTANT MEMORY 2000) | DXH | 1995-05-10 | 363 |
| K924187 | INSTANT MEMORY 2000 | DXH | 1993-06-16 | 300 |
| K883358 | TELESCAN INSTANT MEMORY ECG RECORDER MODEL T-35CM | DXH | 1988-10-13 | 65 |
| K871587 | THE TELESCAN C.A.R.E. SYSTEM | DSH | 1987-08-12 | 110 |
| K820276 | TELESCAN T-30 | DXH | 1982-02-12 | 10 |
Recalls
openFDA lists no recalls under a recalling firm named Telescan Medical Systems.
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.
- Telescan Corp. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Telescan Medical Systems?
FDA lists 5 510(k) clearances under the applicant name “Telescan Medical Systems” (first 1982, latest 1995), across 2 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 Telescan Medical Systems?
The median time from FDA receipt to decision across 510(k)s cleared under the name Telescan Medical Systems is 110 days.
Which FDA product codes appear under Telescan Medical Systems?
The most frequent FDA product codes under this applicant name are DXH (Transmitters And Receivers, Electrocardiograph, Telephone, 4); DSH (Recorder, Magnetic Tape, Medical, 1).
Next steps
- See all 5 Telescan Medical Systems clearances with predicates and recalls
- Run predicate analysis for product code DXH, Telescan Medical Systems'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.