510(k) · Cleared
ClearedPortable Ultrasonic Diagnostic System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sonoscape Company Limited · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Dec 21, 2012 as substantially equivalent to K101337 (Sonoscape Company Limited, 2010) after a 28-day review. Its family tree reaches back 11 generations to 1995.
- Decided
- Dec 21, 2012
- Review
- 28 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K935595 (1995). 42 ancestors in all, the oldest K852159 (1985). No later device cites it as a predicate yet.
- Root · 11 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 7 generations between
- 3 generations backK061189 DP-9900 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
- 2 generations backK070526 DP-9900 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007
- 1 generation backK101337 A6 Portable Ultrasonic Diagnostic SystemSonoscape Company Limited · 2010
- This deviceK123616 Portable Ultrasonic Diagnostic SystemSonoscape Company Limited · 2012
Show all 11 generations
- Root · 11 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 10 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 9 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 8 generations backK032111 Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 7 generations backK040060 Sonoline G50 and G60 S Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2004
- 6 generations backK043078 Nemio Diagnostic Ultrasound System, Model Ssa-550AToshiba America Medical Systems, In.C · 2004 · Recalled
- 5 generations backK051500 Famio Diagnostic Ultrasound Systems, Model Ssa-530AToshiba America Medical Systems, In.C · 2005
- 4 generations backK053346 Modification to: DP-9900 Digital Ultrasonic Diagnostic Imaging…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2005
- 3 generations backK061189 DP-9900 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
- 2 generations backK070526 DP-9900 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007
- 1 generation backK101337 A6 Portable Ultrasonic Diagnostic SystemSonoscape Company Limited · 2010
- This deviceK123616 Portable Ultrasonic Diagnostic SystemSonoscape Company Limited · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −10 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −9 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −8 | K032111 | Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2003 | 1 |
| −7 | K040060 | Sonoline G50 and G60 S Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −6 | K043078 | Nemio Diagnostic Ultrasound System, Model Ssa-550A | Toshiba America Medical Systems, In.C | 2004 | 1 |
| −5 | K051500 | Famio Diagnostic Ultrasound Systems, Model Ssa-530A | Toshiba America Medical Systems, In.C | 2005 | — |
| −4 | K053346 | Modification to: DP-9900 Digital Ultrasonic Diagnostic Imaging System, Model… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2005 | — |
| −3 | K061189 | DP-9900 Digital Ultrasonic Diagnostic Imaging System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006 | — |
| −2 | K070526 | DP-9900 Digital Ultrasonic Diagnostic Imaging System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2007 | — |
| −1 | K101337 | A6 Portable Ultrasonic Diagnostic System | Sonoscape Company Limited | 2010 | — |
| 0 (this device) | K123616 | Portable Ultrasonic Diagnostic System | Sonoscape Company Limited | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1999 | 6 | 0 |
| 2000 | 5 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 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? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K101337 | A6 Portable Ultrasonic Diagnostic SystemSummary page 2…21 CER 892.1570 Diagnostic Ultrasound Transducer(90-ITX) Legally Marketed Predicate Device: SonoScape A6 Portable Ultrasonic Diagnostic System * 510(k):Number: K101337: Description: The A6 Portable Ultrasonic Diagnostic System with added transducer is a genra~rl purpose, portable, software… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 17 years and passes through 5 companies; a new generation was cleared every 10 months on median.
- 4 of the 42 ancestors have a recall of any class.
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. 2012, this device’s year, is highlighted.
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 A6 Portable Ultrasonic Diagnostic System with added transducer is a general-purpose
ultrasonic imaging instrument intended for use by a qualified physician for evaluation of
Abdomen, Cardiac, Small Organ (Thyroid, parathyroid, parotid, submaxillar, gland, testes
and breast.), Peripheral Vascular, Trans-vaginal, Trans-rectal, Musculo-skeletal
(Conventional and Superficial), Pediatric, Fetal, OB/Gyn and Urology. This device is
intended to adult, pregnant woman, pediatric, and neonate.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123616 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123616: Portable Ultrasonic Diagnostic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123616
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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