Bac
by Deephealth
510(k) K254131
Bac is a medical device (FDA Class II; FDA product code QIH, Automated Radiological Image Processing Software) made by Deephealth, cleared under FDA 510(k) K254131 on 21 May 2026, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK254131 | Date21 May 2026 | StatusActive |
Official records
- FDA 510(k) database K254131
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- QIH
- FDA applicant
- DeepHealth, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K254131
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Breast Arterial Calcification (BAC) 1.y.z | 1.y.z | 00860005144099 | — | On the market |
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