BrightHeart View Classifier
510(k) K251456
BrightHeart View Classifier is a medical device (FDA Class II; FDA product code QIH, Automated Radiological Image Processing Software) made by Brightheart, cleared under FDA 510(k) K251456 on 5 Jun 2025, 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 | NumberK251456 | Date5 Jun 2025 | StatusActive |
Official records
- FDA 510(k) database K251456
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- QIH
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K251456
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 | |||
|---|---|---|---|---|
| B-Right Views Fetal Heart V1.x | V1.x | 03760415600031 | — | On the market |
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