FDA product code · Radiology
LLZSystem, Image Processing, Radiological
Product code LLZ covers System, Image Processing, Radiological, a Class II device regulated under 21 CFR 892.2050. FDA has cleared 2,281 devices in this code, 52 of them in the last 12 months. Median review time across the 2,281 most recent decisions is 78 days. openFDA lists 552 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 892.2050
- Review panel
- Radiology
- Clearances
- 2,281
What is happening in LLZ right now?
LLZ (System, Image Processing, Radiological) has five findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2874-2026, Z-2875-2026, Z-2771-2026, Z-2553-2026, Z-1805-2026). Adverse events reported in 2026-03 ran high — 60 reports against an expected 0 to 42 (LLZ:MAUDE:2026-03). 27 first-time filers in the last 12 months, including ResolutionMD, Inc. and Avara Software (K260500, K262120, K253899, K261465, K260231). Clearances are running 82% slower — a median 142 days over the last 12 months against 78 days all-time (elapsed calendar days, not FDA review days) (LLZ:review_time:12m). The code is crowded, scoring 100 of 100 — 985 companies hold a clearance here and 52 arrived in the last 12 months (LLZ:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-2874-2026, Z-2875-2026, Z-2771-2026, Z-2553-2026, Z-1805-2026 |
| Adverse-event spike | Serious | LLZ:MAUDE:2026-03 |
| New entrant | Worth knowing | K260500, K262120, K253899, K261465, K260231 |
| Review time | Context | LLZ:review_time:12m |
| Crowding | Context | LLZ: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.
What does product code LLZ cover?
LLZ is FDA's product code for System, Image Processing, Radiological, a Class II device regulated under 21 CFR 892.2050.
A radiological image processing system.
Source: openFDA device/classification · record LLZ · retrieved
How many devices has FDA cleared in LLZ?
FDA has cleared 2,281 devices under product code LLZ since the 510(k) programme began in 1976, 52 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262462 | TheraSphere 360 Y-90 Management Platform | Boston Scientific Corporation | |
| K262143 | ImageGrid StreamVue | Candelis, Inc. | |
| K260500 | ResolutionMD | ResolutionMD, Inc. | |
| K262120 | Avara Viewer | Avara Software | |
| K253899 | 3D-Anywhere | Provect.AI | |
| K261465 | INDIRA CLOUD VIEWER | INDIGO TECHNOLOGIES | |
| K260576 | MeVis AVM Contour | MeVis Medical Solutions AG | |
| K260231 | MiPACS V5 (1.0.0) | Apryse Software Corp | |
| K253421 | Perfusion Measurement Platform v1 | Quantified Imaging Limited | |
| K261352 | 2D Hip Planning Software | One Ortho |
How long does FDA review take for LLZ?
The median FDA review time for LLZ is 78 days, measured across the 2,281 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 LLZ?
openFDA lists 552 recall records against product code LLZ. A recall record covers one firm's corrective action and may span many device lots.
Z-2874-2026Open, ClassifiedMerge Healthcare Incorporated
Merge Healthcare has identified a potential issue that may cause thumbnails from a previously opened patient study to be displayed in the Thumbnail Bar while a different patient study is open.
Z-2875-2026Open, ClassifiedMerge Healthcare Incorporated
Merge Healthcare has identified a potential issue that may cause thumbnails from a previously opened patient study to be displayed in the Thumbnail Bar while a different patient study is open.
Z-2771-2026Open, ClassifiedBoston Scientific Corporation
Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more input. When a user modifies an input and selects "Recalculate", the dose calculation is updated correctly; however, any vials that were previously added to the cart are not automatically updated to reflect the revised calculation.
Z-2553-2026Open, ClassifiedGE Medical Systems SCS
GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches an interactive application (e.g. Volume Viewer), the application may open the previous patient's exam instead of the intended one. When this issue occurs, there is no system warning or error notification. If the error is not recognized, a clinical user could review, interpret, or report images for the wrong patient which could lead to misdiagnosis, incorrect clinical decisions, resulting in delayed or incorrect treatment.
Z-1805-2026Open, ClassifiedPhilips Medical Systems Nederland B.V.
Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) ratio of AneurysmFlow (Interventional Tool). Philips has determined that the MAFA ratio does not provide reliable prognostic information regarding aneurysm occlusion following Flow Diverter Stent treatment, however despite being stated in the IUF, it is being relied on for making clinical decisions.
Showing the 5 most recently initiated of 552. 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 LLZ?
MAUDE holds 269 adverse-event reports naming product code LLZ, 179 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 LLZ unusual?
2 months sit above LLZ's own expected range: 1 October 2025, 1 March 2026.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 3 | Insufficient history | No expected range — too little history | |
| 4 | 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 | |
| 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 | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | 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 | |
| 6 | Insufficient history | No expected range — too little history | |
| 2 | 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 | |
| 18 | Insufficient history | No expected range — too little history | |
| 15 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 5 | 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 | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | 0–21 | Within expected (0–21) | |
| 4 | 0–15 | Within expected (0–15) | |
| 13 | 0–16 | Within expected (0–16) | |
| 44 | 0–20 | Above expected (0–20) | |
| 7 | 0–39 | Within expected (0–39) | |
| 20 | 0–40 | Within expected (0–40) | |
| 21 | 0–47 | Within expected (0–47) | |
| 10 | 0–40 | Within expected (0–40) | |
| 60 | 0–42 | Above expected (0–42) |
22 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 LLZ.
Who has entered LLZ in the last year?
8 companies filed in LLZ for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| ResolutionMD, Inc. | K260500 | |
| Avara Software | K262120 | |
| Provect.AI | K253899 | |
| INDIGO TECHNOLOGIES | K261465 | |
| Apryse Software Corp. | K260231 | |
| Quantified Imaging Limited | K253421 | |
| One Ortho | K261352 | |
| Customed, Inc | K260116 |
"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 LLZ?
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 LLZ?
Across the 2,281 most recent decisions, these applicants filed most often in LLZ.
| Applicant | Recent clearances |
|---|---|
| Siemens Medical Solutions USA, Inc. | 74 |
| Totoku Electric Co., Ltd. | 40 |
| Barco N.V. | 37 |
| Eizo Nanao Corporation | 34 |
| Vital Images, Inc. | 34 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
Source: openFDA device/510k · retrieved
Watch LLZ
Get an email the morning anything changes in LLZ — 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.