FDA product code QJU: Image Acquisition And/Or Optimization Guided By Artificial Intelligence
QJU is the FDA product code for image acquisition and/or optimization guided by artificial intelligence. It is a Class II device, regulated under 21 CFR 892.2100 and reviewed by the Radiology panel. FDA has cleared 8 510(k) submissions under QJU, 6 in the last five years, from 6 different applicants. The average 510(k) review took 142 days (median 136); 151 days on average over the last three years. 1 De Novo request was granted under it.
Definition
A radiological acquisition and/or optimization guidance system is a device that is intended to aid in the acquisition and/or optimization of images and/or diagnostic signals. The device interfaces with the acquisition system, analyzes its output, and provides guidance and/or feedback to the operator for improving image and/or signal quality.
Classification
| Field | Value |
|---|---|
| Device name | Image Acquisition And/Or Optimization Guided By Artificial Intelligence |
| Device class | Class II |
| Regulation | 21 CFR 892.2100 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
510(k) clearances per year for QJU
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 2 | 44 |
| 2023 | 1 | 265 |
| 2025 | 3 | 178 |
| 2026 | 2 | 124 |
Compare with all 510(k) review times · Search every QJU clearance
Top QJU applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Deski | 2 | 2026-06-03 |
| Caption Health | 2 | 2020-09-18 |
| ThinkSono GmbH | 1 | 2026-07-15 |
| Ultrasight , Ltd. | 1 | 2025-12-17 |
| Caption Health, Inc. | 1 | 2025-01-15 |
1 more applicants have QJU clearances. See the full list in Caduvo.
Most recent QJU clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260338 | ThinkSono GmbH | ThinkSono Guidance | 2026-07-15 | 163 |
| K260780 | Deski | HeartFocus | 2026-06-03 | 85 |
| K251416 | Ultrasight , Ltd. | UltraSight Guidance | 2025-12-17 | 224 |
| K242807 | Deski | HeartFocus (V.1.1.1) | 2025-04-04 | 199 |
| K243065 | Caption Health, Inc. | Cardiac Guidance | 2025-01-15 | 110 |
Recalls for QJU devices
openFDA lists no recalls for product code QJU.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- C2596 — Probe, image-guided, robotic, waterjet ablation
Frequently asked questions
What is FDA product code QJU?
QJU is the FDA product code for image acquisition and/or optimization guided by artificial intelligence. It is a Class II device, regulated under 21 CFR 892.2100 and reviewed by the Radiology panel.
What device class is QJU?
Class II, regulation 21 CFR 892.2100. Typical premarket route: 510(k).
How long does a 510(k) take for product code QJU?
Across 8 cleared submissions the average was 142 days from receipt to decision (median 136).
Which companies have the most QJU clearances?
Deski (2); Caption Health (2); ThinkSono GmbH (1); Ultrasight , Ltd. (1); Caption Health, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QJU
- Run a recall and safety report across every QJU manufacturer
- Watch product code QJU for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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