FDA product code · Radiology · Class 2
IYN: System, Imaging, Pulsed Doppler, Ultrasonic
IYN is FDA's product code for "System, Imaging, Pulsed Doppler, Ultrasonic": a Class 2 device classified under 21 CFR 892.1550, reviewed by the Radiology panel.
510(k) review time for IYN
Across 453 510(k) clearances under IYN decided from 2018-01-01 to 2026-10-06, the median was 103 days from FDA receipt to decision. Half took between 59 and 140 days, and 80% were decided within 163 days. These are past clearances, not a forecast for a new submission.
| Fastest | 14 |
|---|---|
| 25th percentile | 59 |
| Median | 103 |
| 75th percentile | 140 |
| 80th percentile | 163 |
| 90th percentile | 223 |
| Slowest | 531 |
| Year | Median days | n |
|---|---|---|
| 2018 | 85 | 59 |
| 2019 | 79 | 47 |
| 2020 | 72 | 57 |
| 2021 | 105 | 46 |
| 2022 | 105 | 53 |
| 2023 | 115 | 44 |
| 2024 | 119 | 50 |
| 2025 | 124 | 57 |
| 2026 (to 10-06, partial) | 103 | 40 |
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.
IYN in the public FDA record
| 510(k) clearances, all years | 1,183 |
|---|---|
| Device recalls | 298 |
| Establishment listings | 2,775 |
| GUDID device identifiers | 5,056 |
Counts of records, not of devices or events. Adverse event reports for IYN 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 IYN
12 FDA recognized consensus standards cite IYN, among them NEMA UD 2-2004 (R2009); IEC 61391-2 Edition 1.0 2010-01; IEC 62127-03 Edition 1.1 2013-05. 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
- 12-228 IEC 61391-2 Edition 1.0 2010-01 — Ultrasonics - Pulse-echo scanners - Part 2: Measurement of maximum depth of penetration and local dynamic range
- 12-279 IEC 62127-03 Edition 1.1 2013-05 — Ultrasonics -- Hydrophones -- Part 3: Properties of hydrophones for ultrasonic fields up to 40 MHz
- 12-291 IEC 62127-2 Edition 1.2 2017-03 CONSOLIDATED VERSION — Ultrasonics -- Hydrophones -- Part 2: Calibration for ultrasonic fields up to 40 MHz
- 12-292 IEEE Std 3333.2.1-2015 — IEEE Recommended Practice for Three-Dimensional (3D) Medical Modeling
- 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
- 12-312 IEC 61391-1 Edition 1.1 2017-07 CONSOLIDATED VERSION — Ultrasonics - Pulse-echo scanners - Part 1: Techniques for calibrating spatial measurement systems and measurement of system point-spread function response
- 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
- 12-343 IEC 62127-1 Edition 2.0 2022-03 — Ultrasonics - Hydrophones - Part 1: Measurement and characterization of medical ultrasonic fields
- 12-377 IEC 62127-03 Edition 2.0 2022-12 — Ultrasonics -- Hydrophones -- Part 3: Properties of hydrophones for ultrasonic fields up to 40 MHz
- 12-379 IEC 62127-2 Edition 2.0 2025-01 — Ultrasonics -- Hydrophones -- Part 2: Calibration for ultrasonic fields up to 40 MHz
- 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.