Rho
FDA 510(k) clearance DEN230023 · decided 2024-04-09
Clearance details
- K-number
- DEN230023
- Device name
- Rho
- Applicant
- 16 Bit, Inc.
- Decision
- Unknown
- Date received
- 2023-04-03
- Decision date
- 2024-04-09
- Days to decision
- 372 days
- Clearance type
- Direct
- Product code
- SAO
- Device class
- 2
- Regulation number
- 892.1171
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Ancaster, CA
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
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|---|---|---|
| DeepXray Spina (K253192) | Alpha Intelligence Manifolds, Inc. | 2026-06-10 |
| OsteoSightâ„¢ Hip (v1) (K251408) | Naitive Technologies, Ltd. | 2025-09-02 |
Recalls involving this device
No recalls on record reference this clearance.