K243863 is an FDA 510(k) clearance for the Opulus™ Lymphoma Precision. This device is classified as a Automated Radiological Image Processing Software (Class II - Special Controls, product code QIH).
Submitted by Roche Molecular Systems, Inc. (Santa Clara, US). The FDA issued a Cleared decision on May 30, 2025, 164 days after receiving the submission on December 17, 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 | K243863 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 17, 2024 |
| Decision Date | May 30, 2025 |
| Days to Decision | 164 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. |