FDA product code · Radiology · Class 2
ITX: Transducer, Ultrasonic, Diagnostic
ITX is FDA's product code for "Transducer, Ultrasonic, Diagnostic": a Class 2 device classified under 21 CFR 892.1570, reviewed by the Radiology panel.
510(k) review time for ITX
Across 30 510(k) clearances under ITX decided from 2018-01-01 to 2026-10-06, the median was 136 days from FDA receipt to decision. Half took between 95 and 242 days, and 80% were decided within 253 days. These are past clearances, not a forecast for a new submission.
| Fastest | 10 |
|---|---|
| 25th percentile | 95 |
| Median | 136 |
| 75th percentile | 242 |
| 80th percentile | 253 |
| 90th percentile | 266 |
| Slowest | 442 |
| Year | Median days | n |
|---|---|---|
| 2023 | 213 | 6 |
| 2026 (to 10-06, partial) | 158 | 6 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
ITX in the public FDA record
| 510(k) clearances, all years | 414 |
|---|---|
| Device recalls | 147 |
| Establishment listings | 3,360 |
| GUDID device identifiers | 8,904 |
Counts of records, not of devices or events. Adverse event reports for ITX are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite ITX
5 FDA recognized consensus standards cite ITX, among them NEMA UD 2-2004 (R2009); IEC 61161 Edition 3.0 2013-01; IEC 60601-2-37 Edition 2.1 2015. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 12-105 NEMA UD 2-2004 (R2009) — Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3
- 12-275 IEC 61161 Edition 3.0 2013-01 — Ultrasonics -- Power measurement -- Radiation force balances and performance requirements
- 12-293 IEC 60601-2-37 Edition 2.1 2015 — Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
- 12-316 IEC 62359 Edition 2.1 2017-09 CONSOLIDATED VERSION — Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields
- 12-380 IEC 60601-2-37 Edition 3.0 2024-07 — Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.