510(k) K213544
K213544 is an FDA 510(k) premarket notification submitted by Tomtec Imaging Systems GmbH for the device "TOMTEC-ARENA". The FDA issued a decision of Substantially Equivalent on January 6, 2022. The device falls under product code QIH (Automated Radiological Image Processing Software), a Class II device regulated under 21 CFR 892.2050. Tomtec Imaging Systems GmbH has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 6, 2022
- Date Received
- November 8, 2021
- Clearance Type
- Traditional
- 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.