Biosound Esaote, Inc.: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Biosound Esaote, Inc.” (first 1997, latest 2003), across 9 product codes in 3 review panels. Median 510(k) review time under this name: 80 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 7 | 7 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 4 | 4 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 3 | 3 |
| DPS | Electrocardiograph | 1 | 1 |
| GWQ | Full-Montage Standard Electroencephalograph | 1 | 1 |
| ITX | Transducer, Ultrasonic, Diagnostic | 1 | 1 |
| LHN | System, Radiation Therapy, Charged-Particle, Medical | 1 | 1 |
| LOS | 1 | 1 | |
| MOS | Coil, Magnetic Resonance, Specialty | 1 | 1 |
Review panels
- Radiology (17)
- Cardiovascular (1)
- Neurology (1)
Most recent Biosound Esaote, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K023255 | TECHNOS MP, MODEL AU6 | IYN | 2003-02-11 | 134 |
| K014168 | AU6 (TECHNOS/TECHNOS MP) ULTRASOUND IMAGING SYSTEM (ADDITION OF 3D IMAGING MODE AND MUSCULOSKELETAL INDICATION) | IYN | 2002-04-25 | 127 |
| K020164 | E-SCAN XQ | LNH | 2002-02-12 | 26 |
| K012728 | E-SCAN MRI SYSTEM | MOS | 2001-08-29 | 14 |
| K010405 | 7230 ULTRASOUND IMAGING SYSTEM WITH TEI | IYN | 2001-03-13 | 29 |
| K010057 | MODIFICATION TO ARTOSCAN M | LNH | 2001-02-02 | 25 |
| K001894 | MODIFICATION TO E-SCAN | LNH | 2000-07-06 | 15 |
| K000931 | AU5 ULTRASOUND IMAGING SYSTEM | IYN | 2000-06-08 | 78 |
| K000681 | AU5, AU6 | IYO | 2000-05-03 | 65 |
| K994369 | 7250 (MEGAS) | IYN | 2000-02-24 | 59 |
10 earlier clearances. See the full list in Caduvo.
Recalls
5 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2014-06-26.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Biosound Esaote, Inc. (a text match, not an official crosswalk):
- C8903 — Magnetic resonance imaging with contrast, breast; unilateral (via LNH)
- C8906 — Magnetic resonance imaging with contrast, breast; bilateral (via LNH)
- C8905 — Magnetic resonance imaging without contrast followed by with contrast, breast; unilateral (via LNH)
- C8908 — Magnetic resonance imaging without contrast followed by with contrast, breast; bilateral (via LNH)
- C8900 — Magnetic resonance angiography with contrast, abdomen (via MOS)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Biosound, Inc. (39 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Biosound Esaote, Inc.?
FDA lists 20 510(k) clearances under the applicant name “Biosound Esaote, Inc.” (first 1997, latest 2003), across 9 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Biosound Esaote, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biosound Esaote, Inc. is 80 days.
Which FDA product codes appear under Biosound Esaote, Inc.?
The most frequent FDA product codes under this applicant name are IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 7); LNH (System, Nuclear Magnetic Resonance Imaging, 4); IYO (System, Imaging, Pulsed Echo, Ultrasonic, 3).
Next steps
- See all 20 Biosound Esaote, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IYN, Biosound Esaote, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.