Rho - Rho radiology software for opportunistic evaluation of low bone mineral density.
2025-03-31
16 BIT INC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3033583855 | 3033583855 | 16 BIT INC | 1 | N | 2026-01-01 | 20 Bay Street, 11th Floor Toronto Ontario CA M5J 2N8 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 331656 | 2042000044 | DEN230023 | Rho | SAO | 2024-04-09 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| SAO | 1 | 2024-04-09 |