RevealAI-Lung™
Basic Information
- Primary DI
- 00860012425303
- Basic UDI-DI Code
- B-00860012425303
- Reference
- SW-00001
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- Precision Medical Ventures Inc.
Additional Description
RevealAI-Lung Software is a clinical decision support, computer aided diagnostic (CADx) software application intended for analysis of computed tomography (CT) scans of the lung. When a nodule location is provided, the Software automatically compares the nodule characteristics with a clinically established database of lung nodules and provides a similarity score to assist clinicians’ assessment of patients’ cancer risk. RevealAI-Lung Software is designed to be used by radiologists and other healthcare practitioners who are licensed to make diagnostic or other follow-up decisions using radiological imagery and/or radiology reports. The information provided by RevealAI-Lung should only be used in conjunction with other clinically accepted information to guide medical decision-making at the discretion of the clinician.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z11030582 | RADIOLOGY INSTRUMENTS - SOFTWARE ACCESSORIES |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | CE 749991 | BSI Group The Netherlands B.V. | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDD).