Class Class II
BrightHeart View Classifier (K243684)
Description
BrightHeart View Classifier by Brightheart, an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243684
Clearance Date2025-05-07
Clearance TypeTraditional
Product CodeQIH
Regulation Number892.2050
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243684
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. BrightHeart View Classifier (K243684) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K230209 | Sonix Health | Ontact Health Co., Ltd. | 2023 |
| K223387 | V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound S... | Samsung Medison Co., Ltd. | 2023 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K251456 | BrightHeart View Classifier | Brightheart | 2025 |
Trace the full predicate network for K243684
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.