K243633 is an FDA 510(k) clearance for the Brainlab Elements (7.0). This device is classified as a Automated Radiological Image Processing Software (Class II - Special Controls, product code QIH).
Submitted by Brainlab AG (Munich, DE). The FDA issued a Cleared decision on June 13, 2025, 200 days after receiving the submission on November 25, 2024.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050. 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..
| 510(k) Number | K243633 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 25, 2024 |
| Decision Date | June 13, 2025 |
| Days to Decision | 200 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | QIH — Automated Radiological Image Processing Software |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2050 |
| 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. |