510(k) · Cleared
ClearedSiemens Q64XXX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Apr 5, 1996 as substantially equivalent to K904019 (Quantum Medical Systems, Inc., 1991) after a 444-day review. Its family tree reaches back 1 generation to 1991. 1 later device descends from it.
- Decided
- Apr 5, 1996
- Review
- 444 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K904019 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK904019 Quantum 2000 Angiodynograph Ultrasound SystemQuantum Medical Systems, Inc. · 1991
- This deviceK950157 Siemens Q64XXXSiemens Medical Solutions USA, Inc. · 1996
- Descendant · cites it directly · 0 of its ownK981626 Sonoline Elegra Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 1998
Most influential descendants
Showing 1 of 1 · See all- K981626Sonoline Elegra Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K904019 | Quantum 2000 Angiodynograph Ultrasound System | Quantum Medical Systems, Inc. | 1991 | — |
| 0 (this device) | K950157 | Siemens Q64XXX | Siemens Medical Solutions USA, Inc. | 1996 | — |
| +1 | K981626 | Sonoline Elegra Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IYO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K904019 | Quantum 2000 Angiodynograph Ultrasound SystemSummary page 1…Code 90 IYN, 21 CFR 92.1550) Diagnostic Ultrasonic Transducer: (Product Code 90 ITX, 21 CFR 892.1570) 3. Predicate Device: « Siemens Quantum™ 2000 Uitrasound System (K904019/A) Assorted Diagnostic Ultrasound Transducers (KS04019/A) Siemens SONOLINE™ S11200 Ultrasound System (K904564/A) Page 25 === Pa… | 1991 |
| 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…edicate Device: « Siemens Quantum™ 2000 Uitrasound System (K904019/A) Assorted Diagnostic Ultrasound Transducers (KS04019/A) Siemens SONOLINE™ S11200 Ultrasound System (K904564/A) Page 25 Siemens Medical Systems, Inc. Q64XXX Ultrasound System Uttrasound Group , 510(k) Submission 4, Devi… |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K981626 | Sonoline Elegra Diagnostic Ultrasound System | 1998 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K981626 (Siemens Medical Solutions USA, Inc., 1998) has gone furthest, with 0 descendants of its own.
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K950157 · printed Nov 4, 2026
Cite this page
510(k) Report. “K950157: Siemens Q64XXX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K950157
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026