510(k) · Cleared
ClearedLiver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eieling Technology (Shenzhen) Limited · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Feb 6, 2026 as substantially equivalent to K233401 (Eieling Technology Limited, 2024) after a 130-day review. Its family tree reaches back 25 generations to 1995.
- Decided
- Feb 6, 2026
- Review
- 130 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 25 generations to K935595 (1995). 164 ancestors in all, the oldest K894632 (1989). No later device cites it as a predicate yet.
- Root · 25 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 21 generations between
- 3 generations backK203273 FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430…Echosens · 2021
- 2 generations backK212035 FibroScan 230Echosens · 2021
- 1 generation backK233401 Portable Liver Elastography Ultrasound Diagnostic System (Liverscan…Eieling Technology Limited · 2024
- This deviceK253221 Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1…Eieling Technology (Shenzhen) Limited · 2026
Show all 25 generations
- Root · 25 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 24 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 23 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 22 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 21 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 20 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 19 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 18 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 17 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 16 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 15 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 14 generations backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- 13 generations backK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- 12 generations backK110870 Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound…Toshiba America Medical Systems, In.C · 2011
- 11 generations backK121422 Aplio 500/400/300 Diagnostic Ultrasound SystemToshiba Medical Systems Coporation, Japan · 2012
- 10 generations backK123992 Aplio 500/400/300 V3.0Toshibamedical Systems Corporation · 2013
- 9 generations backK133761 Aplio 500/400/300 Diagnostic Ultrasound System V4.0Toshibamedical Systems Corporation · 2014
- 8 generations backK142517 SoftVueDelphinus Medical Technologies, Inc. · 2014
- 7 generations backK150949 FibroScanEchosens · 2015
- 6 generations backK160524 FibroScan 530 CompactEchosens · 2016
- 5 generations backK173034 FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and…Echosens · 2017
- 4 generations backK181547 FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and…Echosens · 2018
- 3 generations backK203273 FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430…Echosens · 2021
- 2 generations backK212035 FibroScan 230Echosens · 2021
- 1 generation backK233401 Portable Liver Elastography Ultrasound Diagnostic System (Liverscan…Eieling Technology Limited · 2024
- This deviceK253221 Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1…Eieling Technology (Shenzhen) Limited · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −25 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −24 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −23 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −22 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −21 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −20 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −19 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −18 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −17 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −16 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −15 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −14 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| −13 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| −12 | K110870 | Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System; Aplio… | Toshiba America Medical Systems, In.C | 2011 | — |
| −11 | K121422 | Aplio 500/400/300 Diagnostic Ultrasound System | Toshiba Medical Systems Coporation, Japan | 2012 | — |
| −10 | K123992 | Aplio 500/400/300 V3.0 | Toshibamedical Systems Corporation | 2013 | — |
| −9 | K133761 | Aplio 500/400/300 Diagnostic Ultrasound System V4.0 | Toshibamedical Systems Corporation | 2014 | — |
| −8 | K142517 | SoftVue | Delphinus Medical Technologies, Inc. | 2014 | — |
| −7 | K150949 | FibroScan | Echosens | 2015 | — |
| −6 | K160524 | FibroScan 530 Compact | Echosens | 2016 | — |
| −5 | K173034 | FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) | Echosens | 2017 | — |
| −4 | K181547 | FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) | Echosens | 2018 | — |
| −3 | K203273 | FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and… | Echosens | 2021 | — |
| −2 | K212035 | FibroScan 230 | Echosens | 2021 | — |
| −1 | K233401 | Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile) | Eieling Technology Limited | 2024 | — |
| 0 (this device) | K253221 | Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro) | Eieling Technology (Shenzhen) Limited | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 8 | 0 |
| 1996 | 3 | 0 |
| 1997 | 9 | 0 |
| 1998 | 4 | 0 |
| 1999 | 11 | 0 |
| 2000 | 7 | 0 |
| 2001 | 7 | 0 |
| 2002 | 11 | 0 |
| 2003 | 13 | 0 |
| 2004 | 14 | 0 |
| 2005 | 10 | 0 |
| 2006 | 9 | 0 |
| 2007 | 3 | 0 |
| 2008 | 8 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2015 | 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 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? (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 |
|---|---|---|---|
| * | K233401 | Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile)Summary page 5… Subsequent Product Code: ITX Regulation Number:21 CFR 892.1560 Class:2 Review Panel: Radiology 4. Predicate Device Information: 510(k) Number: K233401 Device Classification Name: system, imaging, pulsed echo, ultrasonic Sponsor: Eieling Technology (Shenzhen) Limited… | 2024 |
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 31 years and passes through 12 companies; a new generation was cleared every 11 months on median.
- 33 of the 164 ancestors have a recall of any class.
- 1 other device also cites its predicate K233401.
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. 2026, this device’s year, is highlighted.
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?
The FattaLab provides B-mode imaging and is intended to measure ultrasound attenuation coefficient (MAP: Mobile Attenuation Parameter) of liver tissue for adult patients at 3.5MHz. The MAP may be used as an aid to diagnosis and monitoring of adult patients with liver disease, as part of an overall assessment of the liver. This device is intended for use by qualified and appropriately trained healthcare professionals in hospitals, clinics or any facility…
Read the full statement (151 words)
The FattaLab provides B-mode imaging and is intended to measure ultrasound attenuation coefficient (MAP: Mobile Attenuation Parameter) of liver tissue for adult patients at 3.5MHz.
The MAP may be used as an aid to diagnosis and monitoring of adult patients with liver disease, as part of an overall assessment of the liver.
This device is intended for use by qualified and appropriately trained healthcare professionals in hospitals, clinics or any facility where healthcare is provided to measure the ultrasound attenuation coefficient of the liver in patients with liver disease. It does so in a painless and completely non-invasive manner.
To ensure safe and effective operation, the operator shall meet the following requirements:
1) Receive training as required by local, state and national regulations, if applicable
2) Receive additional training as required by the authorized distributor or EIELING
3) Has a thorough knowledge and understanding of the material presented in the labeling
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253221 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253221: Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253221
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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