510(k) · Cleared
ClearedDP-6600 Digital Ultrasonic Diagnostic Imaging 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. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on May 4, 2006 as substantially equivalent to K052113 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2005) and 2 other predicates after a 28-day review. Its family tree reaches back 4 generations to 1995. 191 later devices descend from it.
- Decided
- May 4, 2006
- Review
- 28 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K934139 (1995). 16 ancestors in all, the oldest K852159 (1985). 191 later devices descend from it, 5 citing it directly.
- Root · 4 generations backK934139 Tomtec Echo-ViewTomtec Tomographic Technologies GmbH · 1995
- 3 generations backK993398 Echo View, Easy View, Omni ViewTomtec Imaging Systems GmbH · 1999
- 2 generations backK022824 Echo-View 5.X, Easy-View 2.X, Omni View 2.X, Cardio-View 1.X, LV…Tomtec Imaging Systems GmbH · 2002
- 1 generation backK042540 Philips IU22 Ultrasound SystemPhilips Ultrasound, Inc. · 2004 · Recalled
- This deviceK060949 DP-6600 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
- Descendant · cites it directly · 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 · cites it directly · 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
- Descendant · 2 generations on · 177 of its ownK091941 DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2009
Showing 5 of 191 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 191 · See all- K080640M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008 · cites it directly182descendants
- 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 · cites it directly179descendants
- K083505DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008 · 2 generations on178descendants
- K091941DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2009 · 2 generations on177descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K934139 | Tomtec Echo-View | Tomtec Tomographic Technologies GmbH | 1995 | — |
| −3 | K993398 | Echo View, Easy View, Omni View | Tomtec Imaging Systems GmbH | 1999 | — |
| −2 | K022824 | Echo-View 5.X, Easy-View 2.X, Omni View 2.X, Cardio-View 1.X, LV Analysis 1.X… | Tomtec Imaging Systems GmbH | 2002 | — |
| −1 | K042540 | Philips IU22 Ultrasound System | Philips Ultrasound, Inc. | 2004 | 4 |
| 0 (this device) | K060949 | DP-6600 Digital Ultrasonic Diagnostic Imaging System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006 | — |
| +1 | 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 | — |
| +1 | 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 | — |
| +2 | K091941 | DC-3/DC-3T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 5 | 0 |
| 2009 | 4 | 0 |
| 2010 | 7 | 0 |
| 2011 | 10 | 0 |
| 2012 | 7 | 0 |
| 2013 | 9 | 0 |
| 2014 | 2 | 0 |
| 2015 | 17 | 0 |
| 2016 | 10 | 0 |
| 2017 | 26 | 0 |
| 2018 | 11 | 0 |
| 2019 | 11 | 0 |
| 2020 | 12 | 0 |
| 2021 | 10 | 0 |
| 2022 | 9 | 0 |
| 2023 | 8 | 0 |
| 2024 | 14 | 0 |
| 2025 | 13 | 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 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? (3)
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 |
|---|---|---|---|
| * | K052113 | DP-6600 Ultrasonic Diagnostic Imaging SystemSummary page 2…tic Ultrasound Transducer (90-ITX) 0023 Legally Marketed Predicate Device: K052113 DP-6600 Digital Ultrasonic Diagnostic Imaging System K992663 SSD-5000 Diagnostic Ultrasound System, Aloka Co. Ltd.… | 2005 |
| * | K992663 | Aloka SSD-5500 Diagnostic Ultrasound SystemSummary page 2…0023 Legally Marketed Predicate Device: K052113 DP-6600 Digital Ultrasonic Diagnostic Imaging System K992663 SSD-5000 Diagnostic Ultrasound System, Aloka Co. Ltd. K042540 IU22 Diagnostic Ultrasound System, Phillips Ultrasou… | 1999 |
| * | K042540 | Philips IU22 Ultrasound SystemSummary page 2…eted Predicate Device: K052113 DP-6600 Digital Ultrasonic Diagnostic Imaging System K992663 SSD-5000 Diagnostic Ultrasound System, Aloka Co. Ltd. K042540 IU22 Diagnostic Ultrasound System, Phillips Ultrasound, Inc. Description: The DP-6600 Digital Ultrasonic Diagnostic I… | 2004 |
What descends from it? (191)
See all 1915 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080640 | M5 Diagnostic Ultrasound System | 2008 | 182 |
| K083001 | M5 Diagnostic Ultrasound System | 2008 | 179 |
| K090912 | Digital Ultrasonic Diagnostic Imaging System, Model DP-6900 | 2009 | 114 |
| K091680 | Digital Ultrasonic Diagnostic Imaging System | 2009 | 25 |
| K081873 | Emp-2100 Full Digital Ultrasound Diagnostic Device | 2008 | 3 |
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 2.9 years on median.
- 1 of the 16 ancestors has a recall of any class.
- Of its descendants, K080640 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2008) has gone furthest, with 182 descendants of its own.
- 1 other device also cites its predicate K052113.
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?
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060949 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060949: DP-6600 Digital Ultrasonic Diagnostic 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/K060949
Report an extraction error
Are you the manufacturer?
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