FDA product code · Radiology
ITXTransducer, Ultrasonic, Diagnostic
Product code ITX covers Transducer, Ultrasonic, Diagnostic, a Class II device regulated under 21 CFR 892.1570. FDA has cleared 410 devices in this code, 2 of them in the last 12 months. Median review time across the 410 most recent decisions is 106 days. openFDA lists 147 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 892.1570
- Review panel
- Radiology
- Clearances
- 410
What is happening in ITX right now?
ITX (Transducer, Ultrasonic, Diagnostic) has two findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II, Class III) (Z-1006-2026, Z-1618-2026, Z-1619-2026, Z-1620-2026, Z-1621-2026). The code is crowded, scoring 66 of 100 — 174 companies hold a clearance here and 2 arrived in the last 12 months (ITX:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-1006-2026, Z-1618-2026, Z-1619-2026, Z-1620-2026, Z-1621-2026 |
| Crowding | Context | ITX: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 ITX?
FDA has cleared 410 devices under product code ITX since the 510(k) programme began in 1976, 2 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261014 | Accuro® 3S Needle Guide Kit | Rivanna Medical, Inc. | |
| K250883 | ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R) | Olympus Medical Systems Corporation | |
| K250762 | ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R) | Olympus Medical Systems Corporation | |
| K250524 | Mendaera Guidance System | Mendaera, Inc. | |
| K250469 | Accuro® 3S Needle Guide Kit | Rivanna Medical, Inc. | |
| K241662 | Ultrasound Transducer Cover | Vitrolife Sweden AB | |
| K233965 | UltraDrape UGPIV Barrier and Securement (34-15) | Parker Laboratories, Inc. | |
| K241615 | Transducer Probe Cover | Hony Medical Co., Ltd. | |
| K233109 | TP Pivot Pro Needle Guide | Civco Medical Solutions | |
| K231666 | Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) | FUJIFILM Healthcare Americas Corporation |
How long does FDA review take for ITX?
The median FDA review time for ITX is 106 days, measured across the 410 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 ITX?
openFDA lists 147 recall records against product code ITX. A recall record covers one firm's corrective action and may span many device lots.
Z-1006-2026Open, ClassifiedSheathing Technologies Inc
Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk.
Z-1618-2026Open, ClassifiedPhilips Ultrasound, Inc.
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Z-1619-2026Open, ClassifiedPhilips Ultrasound, Inc.
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Z-1620-2026Open, ClassifiedPhilips Ultrasound, Inc.
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Z-1621-2026Open, ClassifiedPhilips Ultrasound, Inc.
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Showing the 5 most recently initiated of 147. 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 ITX?
MAUDE holds 1,770 adverse-event reports naming product code ITX, 362 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 ITX unusual?
Every month with enough history behind it falls inside ITX's own expected range. Nothing here is unusual for this code.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 9 | Insufficient history | No expected range — too little history | |
| 12 | Insufficient history | No expected range — too little history | |
| 10 | Insufficient history | No expected range — too little history | |
| 11 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 8 | Insufficient history | No expected range — too little history | |
| 9 | Insufficient history | No expected range — too little history | |
| 14 | Insufficient history | No expected range — too little history | |
| 9 | Insufficient history | No expected range — too little history | |
| 72 | Insufficient history | No expected range — too little history | |
| 91 | Insufficient history | No expected range — too little history | |
| 109 | Insufficient history | No expected range — too little history | |
| 117 | Insufficient history | No expected range — too little history | |
| 105 | Insufficient history | No expected range — too little history | |
| 70 | Insufficient history | No expected range — too little history | |
| 50 | Insufficient history | No expected range — too little history | |
| 51 | Insufficient history | No expected range — too little history | |
| 60 | Insufficient history | No expected range — too little history | |
| 41 | Insufficient history | No expected range — too little history | |
| 36 | Insufficient history | No expected range — too little history | |
| 186 | Insufficient history | No expected range — too little history | |
| 49 | 3–164 | Within expected (3–164) | |
| 55 | 0–136 | Within expected (0–136) | |
| 40 | 0–149 | Within expected (0–149) | |
| 44 | 0–144 | Within expected (0–144) | |
| 40 | 0–124 | Within expected (0–124) | |
| 47 | 0–121 | Within expected (0–121) | |
| 44 | 0–187 | Within expected (0–187) | |
| 42 | 0–136 | Within expected (0–136) | |
| 60 | 0–141 | Within expected (0–141) | |
| 49 | 0–143 | Within expected (0–143) | |
| 38 | 0–127 | Within expected (0–127) | |
| 50 | 0–140 | Within expected (0–140) | |
| 38 | 32–81 | Within expected (32–81) | |
| 42 | 20–66 | Within expected (20–66) | |
| 52 | 29–64 | Within expected (29–64) |
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 ITX.
What are the predicate devices in ITX?
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 ITX?
Across the 410 most recent decisions, these applicants filed most often in ITX.
| Applicant | Recent clearances |
|---|---|
| CIVCO Medical Instruments Co., Inc. | 14 |
| Biosound, Inc. | 13 |
| Acuson Corp. | 11 |
| General Electric Co. | 11 |
| Acuson Computed Sonography | 10 |
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 ITX 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 |
|---|---|---|
| CIVCO Medical Instruments Co., Inc. | 15 | 2 |
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 ITX
Get an email the morning anything changes in ITX — 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.