FDA product code · Radiology
JAQSystem, Applicator, Radionuclide, Remote-Controlled
Product code JAQ covers System, Applicator, Radionuclide, Remote-Controlled, a Class II device regulated under 21 CFR 892.5700. FDA has cleared 208 devices in this code, 4 of them in the last 12 months. Median review time across the 208 most recent decisions is 99 days. openFDA lists 52 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 892.5700
- Review panel
- Radiology
- Clearances
- 208
What is happening in JAQ right now?
JAQ (System, Applicator, Radionuclide, Remote-Controlled) has one finding. 3 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2710-2026, Z-2711-2026, Z-2712-2026).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-2710-2026, Z-2711-2026, Z-2712-2026 |
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 JAQ?
FDA has cleared 208 devices under product code JAQ since the 510(k) programme began in 1976, 4 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262383 | LumenCare Azure | Nucletron B.V. | |
| K252717 | MAASTRO Rectal Applicator Set | Varian Medical Systems | |
| K251037 | Rectal Applicator | Nucletron B.V. | |
| K252884 | Guided Aarhus Applicator Set | Varian Medical Systems | |
| K250299 | CT/ MR Tandem and Ovoid Set | Varian Medical Systems, Inc. | |
| K250289 | Intracavitary/Interstitial System | Varian Medical Systems | |
| K243939 | Titanium Flexible Geometry FSD Applicator Set (GM11013400) | Varian Medical Systems, Inc. | |
| K241764 | Mould Probe MR Safe | Varian Medical Systems, Inc. | |
| K242961 | Intraluminal Applicator Set | Varian Medical Systems | |
| K243045 | BRAXX Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002) | Braxx Biotech Co., Ltd. |
How long does FDA review take for JAQ?
The median FDA review time for JAQ is 99 days, measured across the 208 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 JAQ?
openFDA lists 52 recall records against product code JAQ. A recall record covers one firm's corrective action and may span many device lots.
Z-2710-2026Open, ClassifiedElekta Limited
Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.
Z-2711-2026Open, ClassifiedElekta Limited
Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.
Z-2712-2026Open, ClassifiedElekta Limited
Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.
Z-0772-2020TerminatedNucletron BV
A component failure may lead to treatment interruption or incorrect source positioning.
Z-1829-2015TerminatedVarian Medical Systems, Inc.
Varian has discovered that there is a discrepancy in the absolute dose rate given with the Leipzig-style Surface Applicator's Instructions for Use (IFU): Dose Characterization GM11010080 2012-09-06. The actual dose rate of the applicator is approximately 14% higher than the rate published within the IFU. Use of the dose rate as provided by the IFU without modification or independent confirmat
Showing the 5 most recently initiated of 52. 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 JAQ?
MAUDE holds 10 adverse-event reports naming product code JAQ, 6 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 JAQ unusual?
JAQ does not yet have twelve months of adverse-event history in our data, so there is no expected range to compare against. That is a gap in what we hold, not a statement about the device.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 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 | |
| 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 | |
| 3 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history |
8 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.
What are the predicate devices in JAQ?
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 JAQ?
Across the 208 most recent decisions, these applicants filed most often in JAQ.
| Applicant | Recent clearances |
|---|---|
| Varian Medical Systems, Inc. | 50 |
| Mick Radio-Nuclear Instruments, Inc. | 22 |
| Nucletron Corp. | 14 |
| Nucletron Corporation | 10 |
| Nucletron B.V. | 9 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
2 companies in JAQ 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. | 59 | 2 |
| Nucletron BV | 26 | 3 |
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 JAQ
Get an email the morning anything changes in JAQ — 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.