Data / Federal rules / 2025-09837
Medical Devices; Radiology Devices; Classification of the Radiological Acquisition and/or Optimization Guidance System
The Food and Drug Administration published this final rule in the Federal Register on June 2, 2025. It took effect on June 2, 2025.
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What the agency says
The Food and Drug Administration (FDA, the Agency, or we) is classifying the radiological acquisition and/or optimization guidance system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the radiological acquisition and/or optimization guidance system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices in part by reducing regulatory burdens.
Key facts
- Document number
- 2025-09837
- Type
- Final rule
- Action
- Final amendment; final order
- Agency
- Health and Human Services Department; Food and Drug Administration
- Published
- June 2, 2025
- Takes effect
- June 2, 2025
- Dates
- This order is effective June 2, 2025. The classification was applicable on February 7, 2020.
- Docket
- Docket No. FDA-2025-N-1182
- Code of Federal Regulations
- 21 CFR 892
- Topics
- Medical devices; Radiation protection; X-rays
- Pages
- 3
Other documents from the Food and Drug Administration
Everything from the Food and Drug Administration · Rules on medical devices · Rules on radiation protection · Rules on x-rays · Published in June 2025
Read from the Federal Register API, last updated 2026-10-23. The document on federalregister.gov is the official record; dates and dockets can change through later corrections. Free to reuse with credit to SpecStream under CC BY 4.0.