# P970040: Achilles Express Ultrasonometer

- Pathway: PMA
- Applicant: Ge Lunar Corp.
- Decided: Jun 26, 1998 after 297 days
- Product code: MUA (Bone Sonometer)
- Device class: 2
- Regulation: 21 CFR 892.1180
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Most influential descendants
- K103633: Achilles (2011), 4 descendants of its own
- K161919: UltraScan 650 (2017), 3 descendants of its own
- K180516: EchoS (2018), 2 descendants of its own
- K202514: EchoS Family (2021), 1 descendant of its own
- K212851: EchoSK and EchoSGyn modules for EchoS Family devices (2022), 0 descendants of its own

## Recalls of this device
- Sep 3, 2019 · Class II · Z-0112-2020: Certain Achilles Express and Achilles Insight systems were shipped with European CEE-7/7 Type Power Cords to countries where three protruding pin plugs are required for protective earth connection.
- Sep 3, 2019 · Class II · Z-0113-2020: Certain Achilles Express and Achilles Insight systems were shipped with European CEE-7/7 Type Power Cords to countries where three protruding pin plugs are required for protective earth connection.

Source page: https://510kreport.com/device/P970040
Methodology: https://510kreport.com/methodology