510(k) · Cleared
ClearedApogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Jun 27, 2016 as substantially equivalent to K110841 (Shantou Institute of Ultrasonic Instruments (Siui, 2011) and 1 other predicate after a 91-day review. Its family tree reaches back 19 generations to 1995. 5 later devices descend from it.
- Decided
- Jun 27, 2016
- Review
- 91 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 19 generations to K935595 (1995). 178 ancestors in all, the oldest K863700 (1987). 5 later devices descend from it, 2 citing it directly.
- Root · 19 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 15 generations between
- 3 generations backK123001 Acuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2012 · Recalled
- 2 generations backK132804 Acuson S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro · 2013 · Recalled
- 1 generation backK141846 Acuson X700 Ultrasound System, Acuson X600 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2014
- This deviceK160853 Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) · 2016
- Descendant · cites it directly · 3 of its ownK173000 Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) · 2017
- Descendant · 2 generations on · 0 of its ownK243178 Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital…Shantou Institute of Ultrasonic Instruments Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK243132 Digital Color Doppler Ultrasound Imaging System (Readius L15)…Shantou Institute of Ultrasonic Instruments Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK210317 Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) · 2021
- Descendant · cites it directly · 0 of its ownK210318 Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) · 2021
Show all 19 generations
- Root · 19 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 18 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 17 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 16 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 15 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 14 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 13 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 12 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 11 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 10 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 9 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 8 generations backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- 7 generations backK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- 6 generations backK110943 Logiq E9GE Healthcare · 2011 · Recalled
- 5 generations backK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- 4 generations backK121699 Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic…Siemens Medical Solutions USA, Inc. · 2012
- 3 generations backK123001 Acuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2012 · Recalled
- 2 generations backK132804 Acuson S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro · 2013 · Recalled
- 1 generation backK141846 Acuson X700 Ultrasound System, Acuson X600 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2014
- This deviceK160853 Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) · 2016
Most influential descendants
Showing 5 of 5 · See all- K173000Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) · 2017 · cites it directly3descendants
- K243178Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd. · 2025 · 2 generations on0descendants
- K243132Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd. · 2024 · 2 generations on0descendants
- K210317Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) · 2021 · 2 generations on0descendants
- K210318Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −18 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −17 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −16 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −15 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −14 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −13 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −12 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −11 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −10 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −9 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −8 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| −7 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| −6 | K110943 | Logiq E9 | GE Healthcare | 2011 | 2 |
| −5 | K113690 | GE Logiq I, Logiq E and Vivid E | GE Healthcare | 2011 | 1 |
| −4 | K121699 | Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic Ultrasound… | Siemens Medical Solutions USA, Inc. | 2012 | — |
| −3 | K123001 | Acuson X700 Diagnstic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2012 | 2 |
| −2 | K132804 | Acuson S1000 / S2000 / S3000 | Siemens Medical Solutions USA, Inc. Ultrasound Gro | 2013 | 3 |
| −1 | K141846 | Acuson X700 Ultrasound System, Acuson X600 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2014 | — |
| 0 (this device) | K160853 | Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging… | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | 2016 | — |
| +1 | K173000 | Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300… | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | 2017 | — |
| +2 | K243178 | Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color… | Shantou Institute of Ultrasonic Instruments Co., Ltd. | 2025 | — |
| +2 | K243132 | Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color… | Shantou Institute of Ultrasonic Instruments Co., Ltd. | 2024 | — |
| +2 | K210317 | Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W /… | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | 2021 | — |
| +1 | K210318 | Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging… | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 6 | 0 |
| 1996 | 2 | 0 |
| 1997 | 6 | 0 |
| 1998 | 3 | 0 |
| 1999 | 7 | 0 |
| 2000 | 7 | 0 |
| 2001 | 9 | 0 |
| 2002 | 12 | 0 |
| 2003 | 13 | 0 |
| 2004 | 16 | 0 |
| 2005 | 12 | 0 |
| 2006 | 8 | 0 |
| 2007 | 9 | 0 |
| 2008 | 9 | 0 |
| 2009 | 8 | 0 |
| 2010 | 9 | 0 |
| 2011 | 4 | 0 |
| 2012 | 6 | 0 |
| 2013 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2021 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 IYN? 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 IYN device
- #1 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K110841 | Digital Color Doppler Ultrasound Imaging System, Convex / Linear / Phased Array TransducerSummary page 18…umber Device Apogee 3800 Digital Color Doppler 1 SIUI K110841 Ultrasound Imaging System Acu… | 2011 |
| * | K141846 | Acuson X700 Ultrasound System, Acuson X600 Ultrasound SystemSummary page 18…sound Imaging System Acuson X700 2 SIEMENS K141846 Diagnostic Ultrasound System 5.1 Comparison of Indications for Use (IFU) IFU St… | 2014 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 21 years and passes through 7 companies; a new generation was cleared every 11 months on median.
- 46 of the 178 ancestors have a recall of any class.
- Of its descendants, K173000 (Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui), 2017) has gone furthest, with 3 descendants of its own.
How does its category compare?
All IYN devicesIYN System, Imaging, Pulsed Doppler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · IYN
57in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYN
124in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYN
10in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · IYN
610in 2025
MAUDE reports naming product code IYN, 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 | 13 | 26 | 16 | 3 |
| 2008 | 25 | 18 | 12 | 2 |
| 2009 | 18 | 29 | 8 | 9 |
| 2010 | 29 | 67 | 10 | 17 |
| 2011 | 39 | 46 | 8 | 18 |
| 2012 | 43 | 37 | 3 | 20 |
| 2013 | 51 | 60 | 8 | 18 |
| 2014 | 56 | 39 | 2 | 48 |
| 2015 | 54 | 55 | 3 | 116 |
| 2016 | 60 | 56 | 2 | 145 |
| 2017 | 64 | 83 | 0 | 146 |
| 2018 | 59 | 85 | 7 | 85 |
| 2019 | 47 | 79 | 0 | 59 |
| 2020 | 57 | 72 | 4 | 67 |
| 2021 | 46 | 105 | 8 | 213 |
| 2022 | 53 | 105 | 10 | 186 |
| 2023 | 44 | 115 | 4 | 229 |
| 2024 | 50 | 119 | 1 | 266 |
| 2025 | 57 | 124 | 10 | 610 |
| 2026 | 44 | 107 | 2 (1) | — |
What is it indicated for?
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal, Abdominal, Pediatric, Small Organ (Thyroid, Testes, Breast), Neonatal Cephalic, Musculoskeletal (Conventional and Superficial), Cardiac (Adult and Pediatric), Peripheral Vascular, Trans-vaginal, Trans-rectal, Obstetrics/ Gynecology and Urology applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160853 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160853: Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160853
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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