BriefCase-Quantification
BriefCase-Quantification measures the maximum axial diameter of the abdominal aorta on contrast-enhanced CT examinations. It is intended to assist trained specialists reviewing adult…
BriefCase-Quantification measures the maximum axial diameter of the abdominal aorta on contrast-enhanced CT examinations. It is intended to assist trained specialists reviewing adult patients and transitional adolescents aged eighteen or older.
The software receives relevant DICOM image series and uses an algorithm to produce a preview image annotated with the measured diameter. Both the preview and the original unmarked series remain available for review.
Listed Item
BriefCase-Quantification is an Automated Radiological Image Processing Software.
Measurement Review
The annotated diameter is preliminary and must be checked by a radiologist against the full images and clinical information. The software can evaluate normal or aneurysmal abdominal aortas but is not intended for postoperative aortas. The official radiology report provides the final clinically approved measurement.
Who Else Makes It
Concentrated in Beijing (4), Shanghai (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Philips Ultrasound (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 5 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Shanghai United Imaging Healthcare Co., Ltd. | Shanghai | Shanghai | Manufacturer | 12 |
| Beijing Infervision Healthcare Medical Technology Co., Ltd. | Beijing | Beijing | Complaint-file establishment | 4 |
| Wuhan United Imaging Healthcare Co., Ltd. | Wuhan | Hubei | Manufacturer | 4 |
| Keya Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
Record
| Listed by | Aidoc Medical Ltd., Israel |
|---|---|
| FDA product code | QIH |
| Device type | Automated Radiological Image Processing Software |
| Device class | Class 2 |
| Regulation | 21 CFR 892.2050 |
| Establishment | Manufacturer |
| 510(k) | K230534 |
| Record published | 2024-06-04 |
| Record revised | 2026-02-12 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BC.QTF.4.x.y | In distribution | |
| BC.QTF.5.y.z | In distribution | |
| BC.QTF.3.x.y | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Imbio RV/LV | Imbio, LLC | 5 |
| VEA Align | EOS imaging | 4 |
| Qlab Advanced Quantification Software | Philips Ultrasound LLC | 3 |
| uOmnispace | Shanghai United Imaging Healthcare Co., Ltd. | 3 |
| Scenium | Siemens Medical Solutions USA, Inc. | 3 |
| syngo.MI General | Siemens Medical Solutions USA, Inc. | 3 |
| Neosoma Dashboard | Neosoma, Inc. | 3 |
| OrthoNext™ Platform System Software | Orthofix SRL | 3 |
| MI View&GO | Siemens Medical Solutions USA, Inc. | 3 |
| FEops | Feops NV | 3 |
| AI-Rad Companion Brain MR | Siemens Healthcare Limited | 3 |
| Tomtec-Arena | Tomtec Imaging Systems GMBH | 3 |
Showing 12 of 147. All products under Automated Radiological Image Processing Software
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K242203 | 2024-11-22 |
| K241112 | 2024-05-15 |
| K232083 | 2023-11-13 |
| K230534 | 2023-11-08 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.