16 Bit, Inc.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “16 Bit, Inc.”, plus 1 De Novo 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 |
|---|---|---|---|
| SAO | Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density | 1 | 0 |
Review panels
- Radiology (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN230023 | De Novo | Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density | 2024-04-09 |
Recalls
openFDA lists no recalls under a recalling firm named 16 Bit, 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.
Device clinical trials
An industry sponsor named 16 Bit, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT05245851: Clinical Deployment and Validation of Rho (Completed, started 2022-11-21)
Frequently asked questions
How many FDA 510(k) clearances are listed under 16 Bit, Inc.?
FDA lists 0 510(k) clearances under the applicant name “16 Bit, Inc.”, plus 1 De Novo 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 16 Bit, Inc.?
The most frequent FDA product codes under this applicant name are SAO (Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density, 1).
Next steps
- See all 0 16 Bit, Inc. clearances with predicates and recalls
- Run predicate analysis for product code SAO, 16 Bit, 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.