Esaote, S.p.A.: FDA filings under this applicant name
FDA lists 68 510(k) clearances under the applicant name “Esaote, S.p.A.” (first 2003, latest 2026), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 52 days. Since 2017 the median was 88 days, against 107 days for all cleared 510(k)s in the same product codes. 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 | 5 | 34 |
| 2013 | 4 | 126 |
| 2014 | 4 | 47 |
| 2015 | 2 | 152 |
| 2016 | 6 | 74 |
| 2017 | 1 | 133 |
| 2018 | 3 | 24 |
| 2019 | 4 | 37 |
| 2020 | 0 | — |
| 2021 | 1 | 80 |
| 2022 | 1 | 184 |
| 2023 | 1 | 310 |
| 2024 | 1 | 63 |
| 2025 | 3 | 246 |
| 2026 | 4 | 144 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Esaote, S.p.A. took a median 88 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 107 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 34 | 34 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 28 | 28 |
| MOS | Coil, Magnetic Resonance, Specialty | 4 | 4 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 | 1 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
Review panels
- Radiology (68)
Most recent Esaote, S.p.A. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261331 | I-Genius (100019400) | LNH | 2026-07-31 | 100 |
| K253288 | 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) | IYN | 2026-04-06 | 189 |
| K260746 | S-scan Open (100001800) | LNH | 2026-03-27 | 21 |
| K251901 | Magnifico Open (100009900) | LNH | 2026-03-05 | 258 |
| K253310 | 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30) | IYN | 2025-11-25 | 57 |
| K243253 | 6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70) | IYN | 2025-06-18 | 246 |
| K241671 | 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) | IYN | 2025-05-16 | 339 |
| K241133 | Magnifico Open (100009900); Magnifico MSK ( 100009910) | LNH | 2024-06-26 | 63 |
| K230179 | 6440 MyLabX90 | IYN | 2023-11-29 | 310 |
| K212419 | Magnifico Open, Magnifico MSK | LNH | 2022-02-04 | 184 |
58 earlier clearances. See the full list in Caduvo.
Recalls
9 product recalls in 5 recall events; 1 initiated in the last five years. Most recent: 2025-03-14.
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 Esaote, S.p.A. (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.
- Esaote Europe B.V. (7 510(k)s)
- Esaote Biomedica Spa (4 510(k)s)
- Esaote (1 510(k)s)
- Esaote Biomedica Elettronica (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Esaote, S.p.A.?
FDA lists 68 510(k) clearances under the applicant name “Esaote, S.p.A.” (first 2003, latest 2026), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Esaote, S.p.A.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Esaote, S.p.A. is 52 days. Since 2017: 88 days, versus 107 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Esaote, S.p.A.?
The most frequent FDA product codes under this applicant name are IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 34); LNH (System, Nuclear Magnetic Resonance Imaging, 28); MOS (Coil, Magnetic Resonance, Specialty, 4).
Next steps
- See all 68 Esaote, S.p.A. clearances with predicates and recalls
- Run predicate analysis for product code IYN, Esaote, S.p.A.'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.