Opulus Lymphoma Precision
FDA 510(k) K243863 · Roche Molecular Systems, Inc.
510(k) numberK243863
Submission
- Device name
- Opulus Lymphoma Precision
- Applicant
- Roche Molecular Systems, Inc.
Santa Clara, CA, US - Received
- December 17, 2024
- Decision date
- May 30, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QIH – Automated Radiological Image Processing Software
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.2050
- Specialty
- Radiology
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.
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| K261595 | Ceevra Reveal 4QIH · Traditional | Ceevra, Inc. | 08/25/2026SE |
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Questions and answers
When was Opulus Lymphoma Precision cleared by the FDA?
Opulus Lymphoma Precision (K243863) received a 510(k) decision of Substantially Equivalent on May 30, 2025, 164 days after the submission was received.
What is the product code of K243863?
The FDA product code is QIH – Automated Radiological Image Processing Software, a Class II (moderate risk) device regulated under 21 CFR 892.2050.