FDA product code QIH: Automated Radiological Image Processing Software
QIH is the FDA product code for automated radiological image processing software. It is a Class II device, regulated under 21 CFR 892.2050 and reviewed by the Radiology panel. FDA has cleared 331 510(k) submissions under QIH, 299 in the last five years, from 190 different applicants. The average 510(k) review took 156 days (median 140); 151 days on average over the last three years. FDA has posted 2 recalls for QIH devices, 1 initiated in the last five years.
Definition
To provide automated radiological image processing and analysis tools. Software implementing artificial intelligence including nonadaptive machine learning algorithms trained with clinical and/or artificial data. In these devices, the algorithm training data typically impacts device performance. Adaptive AI algorithms are not within scope of this product code.
Classification
| Field | Value |
|---|---|
| Device name | Automated Radiological Image Processing Software |
| Device class | Class II |
| Regulation | 21 CFR 892.2050 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
510(k) clearances per year for QIH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 2 | 190 |
| 2020 | 11 | 158 |
| 2021 | 19 | 154 |
| 2022 | 25 | 171 |
| 2023 | 45 | 171 |
| 2024 | 64 | 149 |
| 2025 | 94 | 154 |
| 2026 | 71 | 150 |
Compare with all 510(k) review times · Search every QIH clearance
Top QIH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Siemens Medical Solutions USA, Inc. | 12 | 2026-06-25 |
| Dia Imaging Analysis, Ltd. | 10 | 2025-03-17 |
| Shanghai United Imaging Healthcare Co., Ltd. | 6 | 2026-04-22 |
| Overjet, Inc. | 5 | 2026-04-10 |
| Siemens Healthcare GmbH | 5 | 2026-04-10 |
185 more applicants have QIH clearances. See the full list in Caduvo.
Most recent QIH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261623 | GE Medical Systems Ultrasound and Primary Care Diagnostics | EchoPAC Software Only / EchoPAC Plug-in (v211) | 2026-09-16 | 124 |
| K261677 | Aramis Global AI Consultancies, LLC | Artificial Intelligence Renal Assessment (AIRA) Version 1 | 2026-09-15 | 117 |
| K260879 | INVIA, LLC | 4DM | 2026-09-10 | 177 |
| K261795 | Omniscient Neurotechnology Pty, Ltd. | Quicktome Software Suite | 2026-09-10 | 104 |
| K251417 | Argus Cognitive, Inc. | ReVISION 2 | 2026-09-09 | 490 |
Recalls for QIH devices
2 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2026-05-07.
| Year | Recalls |
|---|---|
| 2021 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code QIH?
QIH is the FDA product code for automated radiological image processing software. It is a Class II device, regulated under 21 CFR 892.2050 and reviewed by the Radiology panel.
What device class is QIH?
Class II, regulation 21 CFR 892.2050. Typical premarket route: 510(k).
How long does a 510(k) take for product code QIH?
Across 331 cleared submissions the average was 156 days from receipt to decision (median 140).
Which companies have the most QIH clearances?
Siemens Medical Solutions USA, Inc. (12); Dia Imaging Analysis, Ltd. (10); Shanghai United Imaging Healthcare Co., Ltd. (6); Overjet, Inc. (5); Siemens Healthcare GmbH (5).
Have QIH devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2026-05-07.
Next steps
- Run an FDA pathway report with predicate devices for product code QIH
- Run a recall and safety report across every QIH manufacturer
- Watch product code QIH 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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