Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biosound Esaote, Inc. · Predicate Candidate Screening
20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
82 daysmedian FDA review time
201 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K023255 | TECHNOS MP, MODEL AU6 | Biosound Esaote, Inc. | 2003-02-11 | 134 | 0 |
| K014168 | AU6 (TECHNOS/TECHNOS MP) ULTRASOUND IMAGING SYSTEM (ADDITION | Biosound Esaote, Inc. | 2002-04-25 | 127 | 0 |
| K020164 | E-SCAN XQ | Biosound Esaote, Inc. | 2002-02-12 | 26 | 0 |
| K012728 | E-SCAN MRI SYSTEM | Biosound Esaote, Inc. | 2001-08-29 | 14 | 0 |
| K010405 | 7230 ULTRASOUND IMAGING SYSTEM WITH TEI | Biosound Esaote, Inc. | 2001-03-13 | 29 | 0 |
| K010057 | MODIFICATION TO ARTOSCAN M | Biosound Esaote, Inc. | 2001-02-02 | 25 | 0 |
| K001894 | MODIFICATION TO E-SCAN | Biosound Esaote, Inc. | 2000-07-06 | 15 | 0 |
| K000931 | AU5 ULTRASOUND IMAGING SYSTEM | Biosound Esaote, Inc. | 2000-06-08 | 78 | 0 |
| K000681 | AU5, AU6 | Biosound Esaote, Inc. | 2000-05-03 | 65 | 0 |
| K994369 | 7250 (MEGAS) | Biosound Esaote, Inc. | 2000-02-24 | 59 | 0 |
| K990968 | E-SCAN | Biosound Esaote, Inc. | 1999-05-27 | 65 | 0 |
| K990360 | AU6 | Biosound Esaote, Inc. | 1999-04-30 | 84 | 0 |
| K982444 | 7250 ULTRASOUND IMAGING SYSTEM | Biosound Esaote, Inc. | 1998-10-06 | 84 | 0 |
| K980468 | AU5 ULTRASOUND IMAGING SYSTEM | Biosound Esaote, Inc. | 1998-08-26 | 201 | 0 |
| K981358 | ARTOSCAN S | Biosound Esaote, Inc. | 1998-07-13 | 90 | 0 |
| K981293 | 7200 ULTRASOUND IMAGING SYSTEM | Biosound Esaote, Inc. | 1998-06-30 | 82 | 0 |
| K973922 | ARCHIMED 4210 AND 4220 | Biosound Esaote, Inc. | 1998-05-12 | 209 | 0 |
| K974079 | FORMULA FOR ARCHIMED | Biosound Esaote, Inc. | 1998-01-22 | 85 | 0 |
| K971942 | SLED, FINGER, HANDLE | Biosound Esaote, Inc. | 1997-07-23 | 57 | 0 |
| K970703 | GALILEO HALLEY | Biosound Esaote, Inc. | 1997-05-19 | 82 | 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