510(k) · Cleared
ClearedSonoace SA-8000 Diagnostic Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medison America, Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Nov 16, 2001 as substantially equivalent to K002185 (Medison America, Inc., 2000) and 1 other predicate after an 11-day review. Its family tree reaches back 4 generations to 1993. 204 later devices descend from it.
- Decided
- Nov 16, 2001
- Review
- 11 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K924432 (1993). 11 ancestors in all. 204 later devices descend from it, 6 citing it directly.
- Root · 4 generations backK924432 Medison 1500Medison Co., Ltd. · 1993
- 3 generations backK981510 Sonoace 6000/ Ultramark 400Medison America, Inc. · 1998
- 2 generations backK990970 Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also…Medison America, Inc. · 1999
- 1 generation backK002185 Sonoace SA 9900 Diagnostic Ultrasound SystemMedison America, Inc. · 2000 · Recalled
- This deviceK013627 Sonoace SA-8000 Diagnostic Ultrasound SystemMedison America, Inc. · 2001
- Descendant · cites it directly · 184 of its ownK031552 Mycolor 202 Diagnostic Ultrasound System and TransducersMedison America, Inc. · 2003 · Recalled
- Descendant · cites it directly · 182 of its ownK043455 SA8000 SE Diagnostic Ultrasound SystemMedison Co., Ltd. · 2004
- Descendant · cites it directly · 132 of its ownK032329 SA 9900 Plus Diagnostic Ultrasound SystemMedison America, Inc. · 2003
- Descendant · 2 generations on · 131 of its ownK052911 Accuvix XQ Diagnostic Ultrasound SystemMedison Co., Ltd. · 2005
- Descendant · cites it directly · 129 of its ownK063580 Sonoace X8 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2006
Showing 5 of 204 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 204 · See all- K031552Mycolor 202 Diagnostic Ultrasound System and TransducersMedison America, Inc. · 2003 · cites it directly184descendants
- K043455SA8000 SE Diagnostic Ultrasound SystemMedison Co., Ltd. · 2004 · cites it directly182descendants
- K032329SA 9900 Plus Diagnostic Ultrasound SystemMedison America, Inc. · 2003 · cites it directly132descendants
- K052911Accuvix XQ Diagnostic Ultrasound SystemMedison Co., Ltd. · 2005 · 2 generations on131descendants
- K063580Sonoace X8 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2006 · cites it directly129descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K924432 | Medison 1500 | Medison Co., Ltd. | 1993 | — |
| −3 | K981510 | Sonoace 6000/ Ultramark 400 | Medison America, Inc. | 1998 | — |
| −2 | K990970 | Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also Called… | Medison America, Inc. | 1999 | — |
| −1 | K002185 | Sonoace SA 9900 Diagnostic Ultrasound System | Medison America, Inc. | 2000 | 1 |
| 0 (this device) | K013627 | Sonoace SA-8000 Diagnostic Ultrasound System | Medison America, Inc. | 2001 | — |
| +1 | K031552 | Mycolor 202 Diagnostic Ultrasound System and Transducers | Medison America, Inc. | 2003 | 5 |
| +1 | K043455 | SA8000 SE Diagnostic Ultrasound System | Medison Co., Ltd. | 2004 | — |
| +1 | K032329 | SA 9900 Plus Diagnostic Ultrasound System | Medison America, Inc. | 2003 | — |
| +2 | K052911 | Accuvix XQ Diagnostic Ultrasound System | Medison Co., Ltd. | 2005 | — |
| +1 | K063580 | Sonoace X8 Diagnostic Ultrasound System | Medison Co., Ltd. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 6 | 0 |
| 2007 | 3 | 0 |
| 2008 | 4 | 0 |
| 2009 | 5 | 0 |
| 2010 | 7 | 0 |
| 2011 | 9 | 0 |
| 2012 | 5 | 0 |
| 2013 | 7 | 0 |
| 2014 | 9 | 0 |
| 2015 | 5 | 0 |
| 2016 | 11 | 0 |
| 2017 | 15 | 0 |
| 2018 | 17 | 0 |
| 2019 | 17 | 0 |
| 2020 | 11 | 0 |
| 2021 | 13 | 0 |
| 2022 | 14 | 0 |
| 2023 | 10 | 0 |
| 2024 | 9 | 0 |
| 2025 | 13 | 0 |
| 2026 | 8 | 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 |
|---|---|---|---|
| * | K002185 | Sonoace SA 9900 Diagnostic Ultrasound SystemSummary page 2…legally marketed device: Medison America, Inc. believes that SA 8000 ultrasound system is substantially equivalent to the currently marketed SA 9900 ultrasound system (K002185) and SA8800/HDI1500 ultrasound system (K974269) Device Description: The SA8000 scanner is a general purpose, mobile, software c… | 2000 |
| * | K974269 | SA8800 Diagnostic Ultrasound System and Transducers,Summary page 2…. believes that SA 8000 ultrasound system is substantially equivalent to the currently marketed SA 9900 ultrasound system (K002185) and SA8800/HDI1500 ultrasound system (K974269) Device Description: The SA8000 scanner is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its fu… | 1998 |
What descends from it? (204)
See all 2046 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031552 | Mycolor 202 Diagnostic Ultrasound System and Transducers | 2003 | 184 |
| K043455 | SA8000 SE Diagnostic Ultrasound System | 2004 | 182 |
| K032329 | SA 9900 Plus Diagnostic Ultrasound System | 2003 | 132 |
| K063580 | Sonoace X8 Diagnostic Ultrasound System | 2006 | 129 |
| K061213 | Sonoace Pico Diagnostic Ultrasound System | 2006 | 114 |
| K060087 | Accuvix V7 Diagnostic Ultrasound System | 2006 | 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?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K031552 (Medison America, Inc., 2003) has gone furthest, with 184 descendants of its own.
- 4 other devices also cite its predicate K002185.
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.
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?
SA8000 intended uses as defined FDA guidance documents are: Fetal (includes infertility monitoring of follicle development) Abdominal Pediatric Small Organ Neonatal Cephalic Adult Cephalic Cardiac (Adult, Pediatric) Trans-Rectal Trans-Vaginal Peripheral-Vascular Muscular-Skeletal (conventional, superficial) Intra-Operative (Neurological, Abdominal, Peripheral vascular) Typical examinations performed using the system are: General abdominal and pelvic…
Read the full statement (145 words)
SA8000 intended uses as defined FDA guidance documents are:
Fetal (includes infertility monitoring of follicle development)
Abdominal
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac (Adult, Pediatric)
Trans-Rectal
Trans-Vaginal
Peripheral-Vascular
Muscular-Skeletal (conventional, superficial)
Intra-Operative (Neurological, Abdominal, Peripheral vascular)
Typical examinations performed using the system are:
General abdominal and pelvic studies including organ surveys, assessment, and retroperitoneal cavity studies.
Study of small parts including breasts, shoulders, thyroid, and the abdominal wall.
Pediatric scans of organs and bony structures.
Peripheral vascular applications including carotid arteries, legs, arms, feet, and penile artery.
Monitoring procedures for infertility studies (other than in vitro fertilization).
First, second and third trimester pregnancy studies.
Prostate, prostate biopsy guidance, and rectal wall studies.
Neonatal head studies.
Trans-cranial studies of middle cerebral arteries, internal carotid artery, and vertebral arteries.
Cardiac studies in adults and children.
Biopsy guidance for tissue or fluid sampling.
Conventional podiatry scans.
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/K013627 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013627: Sonoace SA-8000 Diagnostic Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013627
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026