LLZ — System, Image Processing, Radiological Class II
FDA product code LLZ covers "System, Image Processing, Radiological", a Class II medical device regulated under 21 CFR 892.2050. Submissions are reviewed by the Radiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LLZ
- Device Class
- Class II
- Regulation Number
- 892.2050
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K261855 | elucid bioimaging | Elucid PlaqueIQ | September 18, 2026 |
| K261861 | mdsim | SPINEsim v1.0 | September 15, 2026 |
| K254214 | taiwan main orthopaedic biotechnology co | OOOPDS | September 15, 2026 |
| K262060 | radiopharmaceutical imaging and dosimetry | 3D-RD-S | September 4, 2026 |
| K261500 | s.m.a.i.o | KBA3D (v2.4.0) | August 17, 2026 |
| K262449 | advahealth solutions | AdvaView | August 14, 2026 |
| K261916 | cortechs labs | NeuroQuant PET | August 12, 2026 |
| K260936 | neurocareai, inc. (dba savelife.ai) | RadioViewAI | July 31, 2026 |
| K260588 | cleerly | Cleerly LABS | July 29, 2026 |
| K262462 | boston scientific corporation | TheraSphere 360 Y-90 Management Platform | July 24, 2026 |
| K262143 | candelis | ImageGrid StreamVue | July 23, 2026 |
| K260500 | resolutionmd | ResolutionMD | July 21, 2026 |
| K262120 | avara software | Avara Viewer | July 10, 2026 |
| K253899 | provect.ai | 3D-Anywhere | July 9, 2026 |
| K261465 | indigo technologies | INDIRA CLOUD VIEWER | July 6, 2026 |
| K260576 | mevis medical solutions | MeVis AVM Contour | June 30, 2026 |
| K260231 | apryse software | MiPACS V5 (1.0.0) | June 25, 2026 |
| K253421 | quantified imaging limited | Perfusion Measurement Platform v1 | June 22, 2026 |
| K261352 | one ortho | 2D Hip Planning Software | June 8, 2026 |
| K260116 | customed | CustoMED Viewer | June 3, 2026 |