510(k) K230197
K230197 is an FDA 510(k) premarket notification submitted by Mriguidance B.V. for the device "BoneMRI v1.6". The FDA issued a decision of Substantially Equivalent on February 22, 2023. The device falls under product code QIH (Automated Radiological Image Processing Software), a Class II device regulated under 21 CFR 892.2050. Mriguidance B.V. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 22, 2023
- Date Received
- January 25, 2023
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Automated Radiological Image Processing Software
- Device Class
- Class II
- Regulation Number
- 892.2050
- Review Panel
- RA
- Submission Type
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.