Mirabel Medical Systems, Inc.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Mirabel Medical Systems, Inc.”, plus 1 PMA decision, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NCL | Imager, Breast, Electrical Impedance | 1 | 0 |
Review panels
- Radiology (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P970033 | PMA | T-SCAN 2000 | 1999-04-16 |
Recalls
openFDA lists no recalls under a recalling firm named Mirabel Medical Systems, Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Mirabel Medical Systems, Inc.?
FDA lists 0 510(k) clearances under the applicant name “Mirabel Medical Systems, Inc.”, plus 1 PMA decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Mirabel Medical Systems, Inc.?
The most frequent FDA product codes under this applicant name are NCL (Imager, Breast, Electrical Impedance, 1).
Next steps
- See all 0 Mirabel Medical Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NCL, Mirabel Medical Systems, Inc.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.