# K950157: Siemens Q64XXX

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Apr 5, 1996 after 444 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K904019 (1991). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K904019: Quantum 2000 Angiodynograph Ultrasound System, Quantum Medical Systems, Inc. (1991) Summary page 1.

## Cited in the summary but kept off the family tree
- K904564: Siemens SONOLINE™ S11200 Ultrasound System. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K981626: Sonoline Elegra Diagnostic Ultrasound System (1998), 0 descendants of its own

## Indications for use
The Q64XXX ultrasound imaging system is intended for the following applications: General Radiology; Abdomen; Intraoperative; Small Parts; Transcranial; OB/GYN; Neonatal Cephalic; Urology; Vascular; Peripheral Vascular; Vascular Doppler. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

Source page: https://510kreport.com/device/K950157
Methodology: https://510kreport.com/methodology