FDA product code · Radiology
IZLSystem, X-Ray, Mobile
Product code IZL covers System, X-Ray, Mobile, a Class II device regulated under 21 CFR 892.1720. FDA has cleared 236 devices in this code, 8 of them in the last 12 months. Median review time across the 236 most recent decisions is 58 days. openFDA lists 170 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 892.1720
- Review panel
- Radiology
- Clearances
- 236
What is happening in IZL right now?
IZL (System, X-Ray, Mobile) has three findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2726-2026, Z-2727-2026, Z-2728-2026, Z-1918-2026, Z-0480-2026). 2 first-time filers in the last 12 months, Shantou Institute of Ultrasonic Instruments Co., Ltd. and Bontech Co., Ltd (K253058, K243864). The code is crowded, scoring 81 of 100 — 117 companies hold a clearance here and 8 arrived in the last 12 months (IZL:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-2726-2026, Z-2727-2026, Z-2728-2026, Z-1918-2026, Z-0480-2026 |
| New entrant | Worth knowing | K253058, K243864 |
| Crowding | Context | IZL: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 IZL?
FDA has cleared 236 devices under product code IZL since the 510(k) programme began in 1976, 8 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253058 | Portable DR Imaging System | Shantou Institute of Ultrasonic Instruments Co., Ltd. | |
| K260085 | RAYMO Mobile X-ray System (Model: RAYMO) | DRGEM Corporation | |
| K253185 | Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System | Carestream Health | |
| K253244 | AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini) | Poskom Co., Ltd. | |
| K250976 | Airbile-100 | Poskom Co., Ltd. | |
| K251710 | Mobile X-ray unit (!M1) | Solutions For Tomorrow AB | |
| K243864 | BONX805 | Bontech Co., Ltd. | |
| K251443 | PROMO | DRGEM Corporation | |
| K251223 | HnX-P1, HnX-PB | H&abyz Co., Ltd. | |
| K250597 | REMEX Xcam6 | Remedi, Inc. |
How long does FDA review take for IZL?
The median FDA review time for IZL is 58 days, measured across the 236 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 IZL?
openFDA lists 170 recall records against product code IZL. A recall record covers one firm's corrective action and may span many device lots.
Z-2726-2026Open, ClassifiedGE Medical Systems, LLC
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column track. This could result in patient injury during an exam.
Z-2727-2026Open, ClassifiedGE Medical Systems, LLC
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column track. This could result in patient injury during an exam.
Z-2728-2026Open, ClassifiedGE Medical Systems, LLC
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column track. This could result in patient injury during an exam.
Z-1918-2026Open, ClassifiedMicro-X Ltd.
X-Ray generator may malfunction resulting in the X-Ray being inoperable.
Z-0480-2026Open, ClassifiedNeuroLogica Corporation
The four (4) M5 bolts that secure the Tube Head Unit to the end of the arm may loosen or fracture due to metal fatigue.
Showing the 5 most recently initiated of 170. 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 IZL?
MAUDE holds 139 adverse-event reports naming product code IZL, 17 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 IZL unusual?
Every month with enough history behind it falls inside IZL's own expected range. Nothing here is unusual for this code.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 3 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 9 | Insufficient history | No expected range — too little history | |
| 8 | Insufficient history | No expected range — too little history | |
| 13 | Insufficient history | No expected range — too little history | |
| 16 | Insufficient history | No expected range — too little history | |
| 7 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 5 | 0–6 | Within expected (0–6) | |
| 2 | 0–6 | Within expected (0–6) | |
| 1 | 0–6 | Within expected (0–6) |
32 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 IZL.
Who has entered IZL in the last year?
2 companies filed in IZL for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Shantou Institute of Ultrasonic Instruments Co., Ltd. | K253058 | |
| Bontech Co., Ltd. | K243864 |
"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 IZL?
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 IZL?
Across the 236 most recent decisions, these applicants filed most often in IZL.
| Applicant | Recent clearances |
|---|---|
| Sedecal., Sa. | 17 |
| Minxray, Inc. | 15 |
| General X-Ray, Inc. | 11 |
| Samsung Electronics Co., Ltd. | 8 |
| DRGEM Corporation | 6 |
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 IZL 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, LLC | 8 | 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 IZL
Get an email the morning anything changes in IZL — 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.