Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
IYN — Predicate Candidate Screening
1,181 FDA 510(k) clearances under this product code; the 50 most recent screened below.
70 daysmedian FDA review time
201 days90th percentile
1,181clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261668 | Venue Go | GE Medical Systems Ultrasound and Primary care Diagnostics, LLC | 2026-08-07 | 79 | 0 |
| K262311 | Alturion Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | 2026-08-04 | 27 | 0 |
| K261835 | LOGIQ Focus | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2026-07-30 | 58 | 0 |
| K261288 | Handheld Ultrasound Scanner | IMGFAX CO., LTD. | 2026-07-30 | 101 | 0 |
| K261412 | V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diag | Samsung Medison Co., Ltd. | 2026-07-28 | 89 | 0 |
| K261211 | Philips EPIQ Series Diagnostic Ultrasound System; Philips Af | Philips Ultrasound, LLC | 2026-07-27 | 104 | 0 |
| K261081 | Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpr | Beijing Konted Medical Technology Co.,Ltd | 2026-07-23 | 113 | 0 |
| K261272 | ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ | Esonic Technology (Wuhan) Co., Ltd. | 2026-07-23 | 97 | 0 |
| K260667 | Alturion Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | 2026-06-29 | 119 | 0 |
| K260844 | ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia S | Siemens Medical Solutions USA, Inc. | 2026-06-16 | 92 | 0 |
| K260748 | ES-Series | E-Scopics | 2026-06-09 | 95 | 0 |
| K260123 | EPIQ Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | 2026-05-27 | 132 | 0 |
| K260680 | EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series D | Philips Ultrasound, LLC | 2026-05-27 | 86 | 0 |
| K260398 | LOGIQ e | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2026-05-26 | 109 | 0 |
| K253949 | SonoPort Series Digital Color Doppler Ultrasound System (Son | CHISON Medical Technologies Co., Ltd. | 2026-05-22 | 163 | 0 |
| K253720 | uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE | Wuhan United Imaging Healthcare Co.,Ltd | 2026-05-21 | 178 | 0 |
| K253716 | uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Eli | Wuhan United Imaging Healthcare Co.,Ltd | 2026-05-15 | 172 | 0 |
| K254028 | Digital Color Doppler Ultrasound System (Autra RS, Autra 90, | Sonoscape Medical Corp. | 2026-05-15 | 150 | 0 |
| K260111 | Palmtop Ultrasound Diagnostic System (MT10P/MT10) | Mytech Intelligence (Shenzhen) Co., Ltd. | 2026-05-14 | 120 | 0 |
| K260846 | Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound Sys | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2026-05-11 | 56 | 0 |
| K261132 | Healium Intelliscan LX192LC | Healium Intelliscan Corporation | 2026-05-05 | 29 | 0 |
| K252558 | Lumify Diagnostic Ultrasound System | Philips Ultrasound, LLC | 2026-05-05 | 265 | 0 |
| K260589 | ES-Series | E-Scopics | 2026-04-29 | 68 | 0 |
| K253288 | 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (M | Esaote, S.p.A. | 2026-04-06 | 189 | 0 |
| K252709 | Wireless Probe Type Ultrasound Scanner | Xuzhou Yongkang Electronic Science Technology Co., Ltd. | 2026-04-02 | 218 | 0 |
| K253595 | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Di | Philips Ultrasound, LLC | 2026-03-27 | 129 | 0 |
| K254099 | EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ult | Samsung Medison Co., Ltd. | 2026-03-27 | 98 | 0 |
| K252148 | Butterfly Gestational Age Tool | Butterfly Network, Inc. | 2026-03-27 | 261 | 0 |
| K260673 | LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita P | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2026-03-24 | 22 | 0 |
| K252433 | Sonio Detect (v3) | Sonio | 2026-03-16 | 227 | 0 |
| K260595 | Sonosite iLOOK Ultrasound System | FUJIFILM Sonosite, Inc. | 2026-03-10 | 15 | 0 |
| K253049 | Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Reson | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2026-02-11 | 142 | 0 |
| K253597 | Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasoun | Canon Medical Systems Corporation | 2026-01-20 | 63 | 0 |
| K253370 | LOGIQ Totus | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2026-01-08 | 100 | 0 |
| K253366 | LOGIQ Fortis | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2026-01-07 | 99 | 0 |
| K252018 | HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic | Samsung Medison Co., Ltd. | 2026-01-05 | 189 | 0 |
| K251268 | Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12 | Edan Instruments, Inc. | 2025-12-23 | 243 | 0 |
| K252557 | Lumify Diagnostic Ultrasound System | Philips Ultrasound, LLC | 2025-12-22 | 131 | 0 |
| K250959 | BioticsAI | Bioticsai, Inc. | 2025-12-22 | 266 | 0 |
| K252498 | Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X | Sonoscape Medical Corp. | 2025-12-05 | 119 | 0 |
| K250791 | ASUS Ultrasound Imaging System (LU800 series) | Asustek Computer, Inc. | 2025-12-04 | 265 | 0 |
| K251601 | Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025-12-03 | 190 | 0 |
| K253310 | 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (M | Esaote, S.p.A. | 2025-11-25 | 57 | 0 |
| K252328 | Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2025-11-24 | 122 | 0 |
| K253487 | ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Sele | Siemens Medical Solutions USA, Inc. | 2025-11-17 | 27 | 0 |
| K253457 | ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper | Siemens Medical Solutions USA, Inc. | 2025-11-13 | 38 | 0 |
| K251853 | Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025-11-07 | 143 | 0 |
| K253448 | Sonosite MT Ultrasound System | FUJIFILM Sonosite, Inc. | 2025-11-03 | 32 | 0 |
| K252074 | Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnost | Canon Medical Systems Corporation | 2025-10-31 | 121 | 0 |
| K251963 | LOGIQ E10s | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2025-10-29 | 125 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda