FDA product code ITX: Transducer, Ultrasonic, Diagnostic
ITX is the FDA product code for transducer, ultrasonic, diagnostic. It is a Class II device, regulated under 21 CFR 892.1570 and reviewed by the Radiology panel. FDA has cleared 414 510(k) submissions under ITX, 20 in the last five years, from 182 different applicants. The average 510(k) review took 151 days (median 108); 130 days on average over the last three years. FDA has posted 147 recalls for ITX devices, 50 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Transducer, Ultrasonic, Diagnostic |
| Device class | Class II |
| Regulation | 21 CFR 892.1570 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for ITX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 6 | 111 |
| 2018 | 2 | 265 |
| 2019 | 1 | 56 |
| 2020 | 3 | 171 |
| 2021 | 3 | 152 |
| 2022 | 2 | 194 |
| 2023 | 6 | 198 |
| 2024 | 3 | 118 |
| 2025 | 4 | 136 |
| 2026 | 5 | 135 |
Compare with all 510(k) review times · Search every ITX clearance
Top ITX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| CIVCO Medical Instruments Co., Inc. | 14 | 2023-11-14 |
| Biosound, Inc. | 13 | 1997-07-09 |
| Acuson Corp. | 11 | 1997-11-05 |
| General Electric Co. | 11 | 1990-08-28 |
| Acuson Computed Sonography | 10 | 1990-05-23 |
177 more applicants have ITX clearances. See the full list in Caduvo.
Most recent ITX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261170 | Fujifilm Corporation | BA-004CC | 2026-08-12 | 125 |
| K254143 | EM-TECH Solutions, Inc. | EM-TECH Passive Ultrasound Probe Strap | 2026-08-10 | 231 |
| K260161 | UC-CARE , Ltd. | SmartGuide Disposable Guides and Grids | 2026-07-30 | 191 |
| K262474 | Accurate Access, LLC | ND Needle Guidance System | 2026-07-27 | 10 |
| K261014 | Rivanna Medical, Inc. | Accuro® 3S Needle Guide Kit | 2026-07-24 | 119 |
Recalls for ITX devices
147 product recalls in 59 recall events; 50 initiated in the last five years and 60 still open. Most recent: 2025-11-17.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 18 |
| 2019 | 4 |
| 2020 | 4 |
| 2021 | 35 |
| 2022 | 6 |
| 2023 | 4 |
| 2024 | 1 |
| 2025 | 38 |
Frequently asked questions
What is FDA product code ITX?
ITX is the FDA product code for transducer, ultrasonic, diagnostic. It is a Class II device, regulated under 21 CFR 892.1570 and reviewed by the Radiology panel.
What device class is ITX?
Class II, regulation 21 CFR 892.1570. Typical premarket route: 510(k).
How long does a 510(k) take for product code ITX?
Across 414 cleared submissions the average was 151 days from receipt to decision (median 108).
Which companies have the most ITX clearances?
CIVCO Medical Instruments Co., Inc. (14); Biosound, Inc. (13); Acuson Corp. (11); General Electric Co. (11); Acuson Computed Sonography (10).
Have ITX devices been recalled?
Yes: 147 product recalls across 59 recall events; the most recent began 2025-11-17.
Next steps
- Run an FDA pathway report with predicate devices for product code ITX
- Run a recall and safety report across every ITX manufacturer
- Watch product code ITX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Radiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times