3D-RD-S— 510(k) K212587
Substantially EquivalentRadiopharmaceutical Imaging and Dosimetry, LLC
FDA 510(k) clearance K212587 for 3D-RD-S, Substantially Equivalent on 2023-02-22. Applicant: Radiopharmaceutical Imaging and Dosimetry, LLC. Device class: 1.
Clearance details
- Applicant
- Radiopharmaceutical Imaging and Dosimetry, LLC
- Product code
- Code IYX
- Device class
- Class 1
- Regulation
- 21 CFR 892.1100
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Baltimore, MD, US
Recent devices under product code IYX
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