FDA product code · Radiology
IYEAccelerator, Linear, Medical
Product code IYE covers Accelerator, Linear, Medical, a Class II device regulated under 21 CFR 892.5050. FDA has cleared 734 devices in this code, 16 of them in the last 12 months. Median review time across the 734 most recent decisions is 90 days. openFDA lists 562 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 892.5050
- Review panel
- Radiology
- Clearances
- 734
What is happening in IYE right now?
IYE (Accelerator, Linear, Medical) has four findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2640-2026, Z-2644-2026, Z-2406-2026, Z-1164-2026, Z-1078-2026). 3 first-time filers in the last 12 months, including Stabilix, LLC and Electrogenics Labs, Ltd (K260792, K250911, K252174). Clearances are running 40% slower — a median 126 days over the last 12 months against 90 days all-time (elapsed calendar days, not FDA review days) (IYE:review_time:12m). The code is crowded, scoring 94 of 100 — 221 companies hold a clearance here and 16 arrived in the last 12 months (IYE:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-2640-2026, Z-2644-2026, Z-2406-2026, Z-1164-2026, Z-1078-2026 |
| New entrant | Worth knowing | K260792, K250911, K252174 |
| Review time | Context | IYE:review_time:12m |
| Crowding | Context | IYE: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 IYE?
FDA has cleared 734 devices under product code IYE since the 510(k) programme began in 1976, 16 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253012 | AlignRT Plus (8.0) | Vision Rt, Ltd. | |
| K252937 | ThinkQA 3 | Dosisoft SA | |
| K253004 | LUNA 3D | Lap GmbH Laser Applikationen | |
| K260792 | AerFrame Patient Immobilization System (AFPIS) | Stabilix, LLC | |
| K252258 | VERIQA RT EPID 3D | Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla | |
| K253962 | ClearCheck (RADCC V2.7) | Radformation, Inc. | |
| K252977 | Halcyon, Ethos Radiotherapy System (5.0) | Varian Medical Systems, Inc. | |
| K252188 | EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy) | Elekta Solutions AB | |
| K254010 | ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface | Brainlab SE | |
| K252988 | ChartCheck (RADCH V1.6) | Radformation, Inc. |
How long does FDA review take for IYE?
The median FDA review time for IYE is 90 days, measured across the 734 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 IYE?
openFDA lists 562 recall records against product code IYE. A recall record covers one firm's corrective action and may span many device lots.
Z-2640-2026Open, ClassifiedAccuray Incorporated
In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and initiate motion using the in-room control pendant, the collimator may release and fall from the housing.
Z-2644-2026Open, ClassifiedAccuray Incorporated
In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and initiate motion using the in-room control pendant, the collimator may release and fall from the housing.
Z-2406-2026Open, ClassifiedElekta Limited
Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.
Z-1164-2026Open, ClassifiedElekta Limited
Due to a manufacturing issue and electrical grounding of systems.
Z-1078-2026Open, ClassifiedElekta Limited
Using oncology information system that manages workflow may result in overtreatment if:Plan delivered with Particle Therapy IHE-RO TDW-II interface,With one field per fraction or last field partial treatment,Partial treatment occurs followed by treatment field interruptions with manually recorded partial treatment,Then treatment unit doesn't check meterset value so partial treatment delivered twice
Showing the 5 most recently initiated of 562. 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 IYE?
MAUDE holds 283 adverse-event reports naming product code IYE, 37 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 IYE unusual?
2 months sit above IYE's own expected range: 1 March 2025, 1 June 2025.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 8 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 7 | Insufficient history | No expected range — too little history | |
| 19 | Insufficient history | No expected range — too little history | |
| 8 | Insufficient history | No expected range — too little history | |
| 12 | Insufficient history | No expected range — too little history | |
| 8 | Insufficient history | No expected range — too little history | |
| 7 | Insufficient history | No expected range — too little history | |
| 13 | Insufficient history | No expected range — too little history | |
| 9 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 8 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 10 | 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 | |
| 7 | Insufficient history | No expected range — too little history | |
| 10 | Insufficient history | No expected range — too little history | |
| 8 | Insufficient history | No expected range — too little history | |
| 9 | 3–11 | Within expected (3–11) | |
| 5 | 3–10 | Within expected (3–10) | |
| 18 | 3–11 | Above expected (3–11) | |
| 6 | 3–19 | Within expected (3–19) | |
| 11 | 1–16 | Within expected (1–16) | |
| 18 | 2–18 | Above expected (2–18) | |
| 4 | 4–34 | Within expected (4–34) | |
| 6 | 0–23 | Within expected (0–23) | |
| 12 | 0–22 | Within expected (0–22) | |
| 3 | 0–23 | Within expected (0–23) | |
| 4 | 0–19 | Within expected (0–19) | |
| 2 | 0–20 | Within expected (0–20) | |
| 5 | 0–23 | Within expected (0–23) | |
| 2 | 0–19 | Within expected (0–19) | |
| 4 | 0–21 | Within expected (0–21) |
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 IYE.
Who has entered IYE in the last year?
3 companies filed in IYE for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Stabilix, LLC | K260792 | |
| Electrogenics Labs, Ltd. | K250911 | |
| Blessing Cathay Corporation | K252174 |
"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 IYE?
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 IYE?
Across the 734 most recent decisions, these applicants filed most often in IYE.
| Applicant | Recent clearances |
|---|---|
| Varian Medical Systems, Inc. | 69 |
| Varian Assoc., Inc. | 27 |
| Brainlab AG | 21 |
| Medtec, Inc. | 20 |
| Siemens Medical Solutions USA, Inc. | 18 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
4 companies in IYE file 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 |
|---|---|---|
| Varian Medical Systems, Inc. | 82 | 2 |
| Medtec Inc Dba Civco Medical Solutions and Civco Radiotherap | 24 | 5 |
| Brainlab AG | 23 | 3 |
| Accuray Incorporated | 19 | 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 IYE
Get an email the morning anything changes in IYE — 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.