FDA product code · Radiology
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
Product code IYN covers System, Imaging, Pulsed Doppler, Ultrasonic, a Class II device regulated under 21 CFR 892.1550. FDA has cleared 1,175 devices in this code, 53 of them in the last 12 months. Median review time across the 1,175 most recent decisions is 70 days. openFDA lists 298 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 892.1550
- Review panel
- Radiology
- Clearances
- 1,175
What is happening in IYN right now?
IYN (System, Imaging, Pulsed Doppler, Ultrasonic) has four findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-0883-2026, Z-0435-2026, Z-0436-2026, Z-0437-2026, Z-0438-2026). 7 first-time filers in the last 12 months, including Wuhan United Imaging Healthcare Co.,Ltd. and Mytech Intelligence (Shenzhen) Co., Ltd (K253716, K260111, K261132, K252709, K250959). Clearances are running 77% slower — a median 124 days over the last 12 months against 70 days all-time (elapsed calendar days, not FDA review days) (IYN:review_time:12m). The code is crowded, scoring 100 of 100 — 236 companies hold a clearance here and 53 arrived in the last 12 months (IYN:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-0883-2026, Z-0435-2026, Z-0436-2026, Z-0437-2026, Z-0438-2026 |
| New entrant | Worth knowing | K253716, K260111, K261132, K252709, K250959 |
| Review time | Context | IYN:review_time:12m |
| Crowding | Context | IYN:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in IYN?
FDA has cleared 1,175 devices under product code IYN since the 510(k) programme began in 1976, 53 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261272 | ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/ MOZI-X1/ MOZI-X12/ DF-41E Diagnostic ultrasound system | Esonic Technology (Wuhan) Co., Ltd. | |
| K261081 | Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro) | Beijing Konted Medical Technology Co.,Ltd | |
| K260667 | Alturion Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | |
| K260844 | ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | |
| K260748 | ES-Series | E-Scopics | |
| K260680 | EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems | Philips Ultrasound, LLC | |
| K260123 | EPIQ Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | |
| K260398 | LOGIQ e | GE Medical Systems Ultrasound and Primary Care Diagnostics | |
| K253949 | SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp, SonoPort 1 Pro, SonoPort 1 Elite, SonoPort 1 Plus, SonoPort 2, SonoPort 2 Exp, SonoPort 2 Pro, SonoPort 2 Elite, SonoPort 2 Plus, SonoPort 3, SonoPort 3 Exp, SonoPort 3 Pro, SonoPort 3 Elite, SonoPort 3 Plus, SonoPort 4, SonoPort 4 Exp, SonoPort 4 Pro, SonoPort 4 Elite, SonoPort 4 Plus, SonoPort 5, SonoPort 5 Exp, SonoPort 5 Pro, SonoPort 5 Elite, SonoPort 5 Plus, SonoPort 6, SonoPort 6 Exp, SonoPort 6 | CHISON Medical Technologies Co., Ltd. | |
| K253720 | uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace, uSONIQUE Grace Elite | Wuhan United Imaging Healthcare Co.,Ltd |
How long does FDA review take for IYN?
The median FDA review time for IYN is 70 days, measured across the 1,175 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in IYN?
openFDA lists 298 recall records against product code IYN. A recall record covers one firm's corrective action and may span many device lots.
Z-0883-2026Open, ClassifiedPhilips Ultrasound, Inc.
Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.
Z-0435-2026Open, ClassifiedB-K Medical A/S
GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions.
Z-0436-2026Open, ClassifiedB-K Medical A/S
GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions.
Z-0437-2026Open, ClassifiedB-K Medical A/S
GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions.
Z-0438-2026Open, ClassifiedB-K Medical A/S
GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions.
Showing the 5 most recently initiated of 298. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for IYN?
MAUDE holds 1,188 adverse-event reports naming product code IYN, 401 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in IYN unusual?
2 months sit above IYN's own expected range: 1 February 2025, 1 April 2025.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 13 | Insufficient history | No expected range — too little history | |
| 14 | Insufficient history | No expected range — too little history | |
| 19 | Insufficient history | No expected range — too little history | |
| 23 | Insufficient history | No expected range — too little history | |
| 19 | Insufficient history | No expected range — too little history | |
| 22 | Insufficient history | No expected range — too little history | |
| 14 | Insufficient history | No expected range — too little history | |
| 22 | Insufficient history | No expected range — too little history | |
| 13 | Insufficient history | No expected range — too little history | |
| 17 | Insufficient history | No expected range — too little history | |
| 23 | Insufficient history | No expected range — too little history | |
| 23 | Insufficient history | No expected range — too little history | |
| 20 | Insufficient history | No expected range — too little history | |
| 20 | Insufficient history | No expected range — too little history | |
| 19 | Insufficient history | No expected range — too little history | |
| 43 | Insufficient history | No expected range — too little history | |
| 16 | Insufficient history | No expected range — too little history | |
| 21 | Insufficient history | No expected range — too little history | |
| 23 | Insufficient history | No expected range — too little history | |
| 13 | Insufficient history | No expected range — too little history | |
| 28 | Insufficient history | No expected range — too little history | |
| 27 | 7–33 | Within expected (7–33) | |
| 48 | 8–31 | Above expected (8–31) | |
| 31 | 9–54 | Within expected (9–54) | |
| 132 | 8–56 | Above expected (8–56) | |
| 39 | 0–120 | Within expected (0–120) | |
| 36 | 0–118 | Within expected (0–118) | |
| 28 | 0–176 | Within expected (0–176) | |
| 41 | 0–122 | Within expected (0–122) | |
| 48 | 0–125 | Within expected (0–125) | |
| 69 | 0–123 | Within expected (0–123) | |
| 45 | 0–116 | Within expected (0–116) | |
| 61 | 0–124 | Within expected (0–124) | |
| 41 | 0–144 | Within expected (0–144) | |
| 44 | 0–116 | Within expected (0–116) | |
| 63 | 0–126 | Within expected (0–126) |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in IYN.
Who has entered IYN in the last year?
7 companies filed in IYN for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Wuhan United Imaging Healthcare Co.,Ltd. | K253716 | |
| Mytech Intelligence (Shenzhen) Co., Ltd. | K260111 | |
| Healium Intelliscan Corporation | K261132 | |
| Xuzhou Yongkang Electronic Science Technology Co., Ltd. | K252709 | |
| Bioticsai, Inc. | K250959 | |
| Asustek Computer, Inc. | K250791 | |
| Wuxi Hisky Medical Technologies Co., Ltd. | K250026 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in IYN?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in IYN?
Across the 1,175 most recent decisions, these applicants filed most often in IYN.
| Applicant | Recent clearances |
|---|---|
| Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 83 |
| Siemens Medical Solutions USA, Inc. | 75 |
| Samsung Medison Co., Ltd. | 67 |
| GE Medical Systems Ultrasound and Primary Care Diagnostics | 58 |
| GE Healthcare | 52 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
One company in IYN files under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC | 69 | 4 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch IYN
Get an email the morning anything changes in IYN — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.