Parascript, LLC: FDA clearances and approvals
Parascript, LLC has 0 FDA 510(k) clearances, plus 1 PMA decision, across 1 product code in 1 review panel.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MYN | Analyzer, Medical Image | 1 | 0 |
Review panels
- Radiology (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P120004 | PMA | PARASCRIPT ACCUDETECT 6.1.0 | 2013-08-22 |
Recalls
openFDA lists no recalls under a recalling firm named Parascript, LLC.
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 Parascript, LLC have?
Parascript, LLC has 0 FDA 510(k) clearances, plus 1 PMA decision, across 1 product code in 1 review panel.
What devices does Parascript, LLC make?
Its most frequent FDA product codes are MYN (Analyzer, Medical Image, 1).
Has Parascript, LLC had device recalls?
openFDA lists no recalls under a recalling firm name matching Parascript, LLC. Related entities may recall under other names.
Next steps
- See all 0 Parascript, LLC clearances with predicates and recalls
- Run predicate analysis for product code MYN, Parascript, LLC'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.