510(k) · Cleared
ClearedDC-6 Diagnostic Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Dec 6, 2006 as substantially equivalent to K010631 (Toshiba America Medical Systems, In.C, 2001) and 6 other predicates after a 16-day review. Its family tree reaches back 9 generations to 1995. 189 later devices descend from it.
- Decided
- Dec 6, 2006
- Review
- 16 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 9 generations to K935595 (1995). 62 ancestors in all, the oldest K852159 (1985). 189 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 5 generations between
- 3 generations backK051500 Famio Diagnostic Ultrasound Systems, Model Ssa-530AToshiba America Medical Systems, In.C · 2005
- 2 generations backK053346 Modification to: DP-9900 Digital Ultrasonic Diagnostic Imaging…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2005
- 1 generation backK061189 DP-9900 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
- This deviceK063500 DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
- Descendant · cites it directly · 188 of its ownK072164 DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007
- Descendant · 2 generations on · 182 of its ownK080640 M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
- Descendant · 2 generations on · 180 of its ownK081320 DC-3, DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
- Descendant · 2 generations on · 179 of its ownK083001 M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
- Descendant · 2 generations on · 178 of its ownK083505 DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
Show all 9 generations
- Root · 9 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 8 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 7 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 6 generations backK032111 Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 5 generations backK040060 Sonoline G50 and G60 S Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2004
- 4 generations backK043078 Nemio Diagnostic Ultrasound System, Model Ssa-550AToshiba America Medical Systems, In.C · 2004 · Recalled
- 3 generations backK051500 Famio Diagnostic Ultrasound Systems, Model Ssa-530AToshiba America Medical Systems, In.C · 2005
- 2 generations backK053346 Modification to: DP-9900 Digital Ultrasonic Diagnostic Imaging…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2005
- 1 generation backK061189 DP-9900 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
- This deviceK063500 DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
Showing 5 of 189 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 189 · See all- K072164DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007 · cites it directly188descendants
- K080640M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008 · 2 generations on182descendants
- K081320DC-3, DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008 · 2 generations on180descendants
- K083001M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008 · 2 generations on179descendants
- K083505DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008 · 2 generations on178descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −8 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −7 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −6 | K032111 | Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2003 | 1 |
| −5 | K040060 | Sonoline G50 and G60 S Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −4 | K043078 | Nemio Diagnostic Ultrasound System, Model Ssa-550A | Toshiba America Medical Systems, In.C | 2004 | 1 |
| −3 | K051500 | Famio Diagnostic Ultrasound Systems, Model Ssa-530A | Toshiba America Medical Systems, In.C | 2005 | — |
| −2 | K053346 | Modification to: DP-9900 Digital Ultrasonic Diagnostic Imaging System, Model… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2005 | — |
| −1 | K061189 | DP-9900 Digital Ultrasonic Diagnostic Imaging System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006 | — |
| 0 (this device) | K063500 | DC-6 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006 | — |
| +1 | K072164 | DC-6 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2007 | — |
| +2 | K080640 | M5 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
| +2 | K081320 | DC-3, DC-3T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
| +2 | K083001 | M5 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
| +2 | K083505 | DC-3/DC-3T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1999 | 7 | 0 |
| 2000 | 5 | 0 |
| 2001 | 6 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 10 | 0 |
| 2005 | 5 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2010 | 6 | 0 |
| 2011 | 9 | 0 |
| 2012 | 6 | 0 |
| 2013 | 9 | 0 |
| 2014 | 2 | 0 |
| 2015 | 17 | 0 |
| 2016 | 10 | 0 |
| 2017 | 25 | 0 |
| 2018 | 12 | 0 |
| 2019 | 11 | 0 |
| 2020 | 13 | 0 |
| 2021 | 10 | 0 |
| 2022 | 9 | 0 |
| 2023 | 8 | 0 |
| 2024 | 13 | 0 |
| 2025 | 15 | 0 |
| 2026 | 6 | 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? (7)
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 |
|---|---|---|---|
| * | K010631 | NEMIOSummary page 1…stic Ultrasound Transducer (90-ITX) 3. Marketed Device: DC-6 Diagnostic Ultrasound System is substantially equivalent to the following devices: Toshiba NEMIO SSA-550A (K#010631) and FAMIO SSA-530A (K#051500). Aloka SSD-5000 (K#012080), Philips iU22 (K#042540), Siemens SONOLINE G60 S (K#052894) and Sequoia… | 2001 |
| * | K051500 | Famio Diagnostic Ultrasound Systems, Model Ssa-530ASummary page 1…-ITX) 3. Marketed Device: DC-6 Diagnostic Ultrasound System is substantially equivalent to the following devices: Toshiba NEMIO SSA-550A (K#010631) and FAMIO SSA-530A (K#051500). Aloka SSD-5000 (K#012080), Philips iU22 (K#042540), Siemens SONOLINE G60 S (K#052894) and Sequoia 512 (K#052410), Mindray DP-99… | 2005 |
| * | K012080 | SSD-5000 Diagnostic Ultrasound SystemSummary page 1…C-6 Diagnostic Ultrasound System is substantially equivalent to the following devices: Toshiba NEMIO SSA-550A (K#010631) and FAMIO SSA-530A (K#051500). Aloka SSD-5000 (K#012080), Philips iU22 (K#042540), Siemens SONOLINE G60 S (K#052894) and Sequoia 512 (K#052410), Mindray DP-9900 (#K061189).… | 2001 |
| * | K042540 | Philips IU22 Ultrasound SystemSummary page 1…System is substantially equivalent to the following devices: Toshiba NEMIO SSA-550A (K#010631) and FAMIO SSA-530A (K#051500). Aloka SSD-5000 (K#012080), Philips iU22 (K#042540), Siemens SONOLINE G60 S (K#052894) and Sequoia 512 (K#052410), Mindray DP-9900 (#K061189).… | 2004 |
| * | K052894 | Sonoline G60 S Ultrasound SystemSummary page 1…to the following devices: Toshiba NEMIO SSA-550A (K#010631) and FAMIO SSA-530A (K#051500). Aloka SSD-5000 (K#012080), Philips iU22 (K#042540), Siemens SONOLINE G60 S (K#052894) and Sequoia 512 (K#052410), Mindray DP-9900 (#K061189). 0042… | 2005 |
| * | K052410 | Acuson Sequoia Ultrasound SystemSummary page 1…Toshiba NEMIO SSA-550A (K#010631) and FAMIO SSA-530A (K#051500). Aloka SSD-5000 (K#012080), Philips iU22 (K#042540), Siemens SONOLINE G60 S (K#052894) and Sequoia 512 (K#052410), Mindray DP-9900 (#K061189). 0042… | 2005 |
| * | K061189 | DP-9900 Digital Ultrasonic Diagnostic Imaging SystemSummary page 1…10631) and FAMIO SSA-530A (K#051500). Aloka SSD-5000 (K#012080), Philips iU22 (K#042540), Siemens SONOLINE G60 S (K#052894) and Sequoia 512 (K#052410), Mindray DP-9900 (#K061189). 0042 B-I === Page 2 ==… | 2006 |
What descends from it? (189)
See all 1891 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072164 | DC-6 Diagnostic Ultrasound System | 2007 | 188 |
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 11 years and passes through 4 companies; a new generation was cleared every 7 months on median.
- 10 of the 62 ancestors have a recall of any class.
- Of its descendants, K072164 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2007) has gone furthest, with 188 descendants of its own.
- 5 other devices also cite its predicate K010631.
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?
The device is intended for use by a qualified physician for ultrasound evaluation of adult abdomen, adult cardiology, pediatric abdomen, pediatric cardiology, fetal cardiology, gynecology, obstetrics (first trimester, second and third trimester), kidney, prostate, thyroid, breast, and other small parts, and peripheral vascular (peripheral artery and peripheral vein), and carotid scanning.
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/K063500 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063500: DC-6 Diagnostic Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063500
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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