Class Class II
TE Air Diagnostic Ultrasound System (K240906)
Description
TE Air Diagnostic Ultrasound System by Shenzhen Mindray Bio-Medical Electronics Co., Ltd., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK240906
Clearance Date2024-07-23
Clearance TypeTraditional
Product CodeIYN
Regulation Number892.1550
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240906
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. TE Air Diagnostic Ultrasound System (K240906) cites 4 predicate devices and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231685 | TE Air Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electr... | 2023 |
| K221300 | Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova,... | Shenzhen Mindray Bio-Medical Electr... | 2022 |
| K212900 | MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vau... | Shenzhen Mindray Bio-Medical Electr... | 2021 |
| K202406 | Butterfly iQ Ultrasound System | Butterfly Network, Inc. | 2020 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K251192 | Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound S... | Shenzhen Mindray Bio-Medical Electr... | 2025 |
| K250024 | TE Air Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electr... | 2025 |
Trace the full predicate network for K240906
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.