510(k) · Cleared
ClearedSIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beijing East Whale Imaging Technology Co., Ltd. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Apr 7, 2016 as substantially equivalent to K102388 (Ge Medical System Israel, Ltd., 2010) after a 59-day review. Its family tree reaches back 7 generations to 2000.
- Decided
- Apr 7, 2016
- Review
- 59 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K000695 (2000). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK000695 GE Dolphin Diagnostic Ultrasound System, Ultrasonic Pulsed Doppler…Ge Medical Systems, Inc. · 2000
- 6 generations backK020789 GE Vivid 3 Expert; GE Vivid 3 ProGeneral Electric Co. · 2002
- 5 generations backK033139 GE Marlin UltrasoundGeneral Electric Co. · 2003 · Recalled
- 4 generations backK061525 GE Vivid - IGeneral Electric Co. · 2006 · Recalled
- 3 generations backK082374 Vivid I and Vivid QGe Medical Systems Israel, Ultrasound, Ltd. · 2008 · Recalled
- 2 generations backK092140 GE Vivid I Diagnostic Ultrasound, GE Vivid Q Diagnostic UltrasoundGe Medical Systems Israel, Ultrasound, Ltd. · 2009 · Recalled
- 1 generation backK102388 Vivid I Diagnostic Ultrasound SystemGe Medical System Israel, Ltd. · 2010 · Recalled
- This deviceK160343 SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic ScannerBeijing East Whale Imaging Technology Co., Ltd. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K000695 | GE Dolphin Diagnostic Ultrasound System, Ultrasonic Pulsed Doppler Imaging… | Ge Medical Systems, Inc. | 2000 | — |
| −6 | K020789 | GE Vivid 3 Expert; GE Vivid 3 Pro | General Electric Co. | 2002 | — |
| −5 | K033139 | GE Marlin Ultrasound | General Electric Co. | 2003 | 1 |
| −4 | K061525 | GE Vivid - I | General Electric Co. | 2006 | 1 |
| −3 | K082374 | Vivid I and Vivid Q | Ge Medical Systems Israel, Ultrasound, Ltd. | 2008 | 2 |
| −2 | K092140 | GE Vivid I Diagnostic Ultrasound, GE Vivid Q Diagnostic Ultrasound | Ge Medical Systems Israel, Ultrasound, Ltd. | 2009 | 2 |
| −1 | K102388 | Vivid I Diagnostic Ultrasound System | Ge Medical System Israel, Ltd. | 2010 | 2 |
| 0 (this device) | K160343 | SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner | Beijing East Whale Imaging Technology Co., Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 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? (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 |
|---|---|---|---|
| * | K102388 | Vivid I Diagnostic Ultrasound SystemSummary page 11…O/ ITX Classification Panel: Radiology Device Class: II 4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)] 510(k) Number K102388 GE Healthcare [GE Medical Systems Ultrasound and Applicant Primary Care Diagnostics,… | 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 16 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 7 of the 9 ancestors have a recall of any class.
- 2 other devices also cite its predicate K102388.
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 Portable Ultrasound Diagnostic Scanner is intended for use by, or under the direction of, a qualified physician for ultrasound imaging and analysis in Abdomen; Small Parts; Obstetrics; Gynecology; Cardiology; Peripheral Vessels; Urology; Pediatrics; Neonate; Trans-cranial; Musculoskeletal; Fetal; Intra-operative; Transvaginal.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160343 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160343: SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160343
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