Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Esaote, S.p.A. — Predicate Candidate Screening
68 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
53 daysmedian FDA review time
189 days90th percentile
68clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261331 | I-Genius (100019400) | Esaote, S.p.A. | 2026-07-31 | 100 | 0 |
| K253288 | 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (M | Esaote, S.p.A. | 2026-04-06 | 189 | 0 |
| K260746 | S-scan Open (100001800) | Esaote, S.p.A. | 2026-03-27 | 21 | 0 |
| K251901 | Magnifico Open (100009900) | Esaote, S.p.A. | 2026-03-05 | 258 | 0 |
| K253310 | 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (M | Esaote, S.p.A. | 2025-11-25 | 57 | 0 |
| K243253 | 6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (M | Esaote, S.p.A. | 2025-06-18 | 246 | 0 |
| K241671 | 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (M | Esaote, S.p.A. | 2025-05-16 | 339 | 0 |
| K241133 | Magnifico Open (100009900); Magnifico MSK ( 100009910) | Esaote, S.p.A. | 2024-06-26 | 63 | 0 |
| K230179 | 6440 MyLabX90 | Esaote, S.p.A. | 2023-11-29 | 310 | 1 |
| K212419 | Magnifico Open, Magnifico MSK | Esaote, S.p.A. | 2022-02-04 | 184 | 0 |
| K212021 | 6430 MyLabX75, 6430 MyLab XPro75 | Esaote, S.p.A. | 2021-09-16 | 80 | 0 |
| K192157 | 6450 Ultrasound system | Esaote, S.p.A. | 2019-11-22 | 105 | 0 |
| K191072 | 7410 Ultrasound System (MyLabSigma) | Esaote, S.p.A. | 2019-06-10 | 49 | 0 |
| K190989 | 6400 Ultrasound System (MyLabX6, MyLabX7) | Esaote, S.p.A. | 2019-05-10 | 25 | 0 |
| K183685 | O-Scan | Esaote, S.p.A. | 2019-01-22 | 25 | 0 |
| K183191 | 6420 Ultrasound System | Esaote, S.p.A. | 2018-12-04 | 15 | 0 |
| K180592 | G-scan Brio | Esaote, S.p.A. | 2018-03-30 | 24 | 0 |
| K173291 | 6440 Ultrasound System | Esaote, S.p.A. | 2018-01-12 | 88 | 0 |
| K163082 | 6200 Ultrasound System and 6250 Ultrasound System | Esaote, S.p.A. | 2017-03-16 | 133 | 0 |
| K161973 | G-scan Brio, S-scan | Esaote, S.p.A. | 2016-10-25 | 99 | 0 |
| K162290 | MyLabSix CrystaLine | Esaote, S.p.A. | 2016-10-14 | 60 | 0 |
| K161359 | 6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasou | Esaote, S.p.A. | 2016-07-19 | 64 | 0 |
| K161238 | S-scan | Esaote, S.p.A. | 2016-07-08 | 67 | 0 |
| K153277 | 6200 Ultrasound System and 6250 Ultrasound System | Esaote, S.p.A. | 2016-05-04 | 174 | 0 |
| K153039 | MRI Dynamic Analysis Plus | Esaote, S.p.A. | 2016-01-08 | 81 | 0 |
| K151668 | S-scan | Esaote, S.p.A. | 2015-09-08 | 81 | 0 |
| K142421 | G-scan Brio | Esaote, S.p.A. | 2015-04-09 | 224 | 1 |
| K142008 | MYLABSEVEN, MYLABALPHA | Esaote, S.p.A. | 2014-09-12 | 51 | 0 |
| K142077 | MYLABGAMMA | Esaote, S.p.A. | 2014-09-12 | 43 | 0 |
| K140677 | MYLABSSOGNO | Esaote, S.p.A. | 2014-04-25 | 38 | 0 |
| K133905 | 6200 / 6250 ULTRASOUND SYSTEM | Esaote, S.p.A. | 2014-04-15 | 113 | 0 |
| K133490 | G-SCAN BRIO | Esaote, S.p.A. | 2013-12-30 | 47 | 0 |
| K131996 | S-SCAN | Esaote, S.p.A. | 2013-12-13 | 168 | 0 |
| K132466 | MYLABSEVEN 6400, MYLABALPHA 7400 | Esaote, S.p.A. | 2013-12-04 | 119 | 0 |
| K132231 | MYLABSEVEN, MYLABALPHA | Esaote, S.p.A. | 2013-11-27 | 132 | 0 |
| K120288 | ORTHOCAD SOFTWARE OPTION | Esaote, S.p.A. | 2012-09-19 | 232 | 0 |
| K122006 | G-SCAN BRIO | Esaote, S.p.A. | 2012-08-06 | 28 | 0 |
| K121650 | S-SCAN | Esaote, S.p.A. | 2012-07-09 | 34 | 0 |
| K121384 | MYLABSOGNO | Esaote, S.p.A. | 2012-05-23 | 15 | 1 |
| K120748 | SPEEDUP SOFTWARE OPTION | Esaote, S.p.A. | 2012-05-01 | 50 | 0 |
| K111302 | MYLABSEVEN, MYLABALPHA | Esaote, S.p.A. | 2011-07-22 | 74 | 0 |
| K111803 | G-SCAN | Esaote, S.p.A. | 2011-07-15 | 18 | 0 |
| K110802 | A-CHANNELS LUMBAT SPINE COILS 17; 4-CHANNELS LUMBAR SPINE CO | Esaote, S.p.A. | 2011-04-08 | 16 | 0 |
| K110373 | TEMPOROMANIBULAR COIL 15 | Esaote, S.p.A. | 2011-04-06 | 57 | 0 |
| K110238 | G-SCAN | Esaote, S.p.A. | 2011-02-17 | 22 | 0 |
| K103152 | 6250 ULTRASOUND SYTEMS | Esaote, S.p.A. | 2011-01-07 | 73 | 0 |
| K100931 | MYLABTWICE, MODEL 6200 | Esaote, S.p.A. | 2010-06-25 | 81 | 0 |
| K100670 | S-SCAN, MODEL 9800020010 | Esaote, S.p.A. | 2010-04-05 | 27 | 0 |
| K092469 | O-SCAN MR SYSTEM | Esaote, S.p.A. | 2009-12-23 | 134 | 0 |
| K091009 | MY LABS25 GOLD/MYLAB30 GOLD CARDIOVASCULAR MODEL 7340, MY LA | Esaote, S.p.A. | 2009-05-18 | 39 | 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