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 |
|---|---|---|---|
| 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 |
| K254265 | videomed srl ( a baxter healthcare corp company) | Helion Viewer Suite | May 27, 2026 |
| K253831 | cercare medical | CMN Capillary Function with Virtual Expert for MRI, CT and CBCT | May 18, 2026 |
| K254013 | subtle medical | SubtleHD-PET (1.x) | May 14, 2026 |
| K260321 | orthopedic driven imaging | HipGuide (V 1.0.0.0) | May 8, 2026 |
| K260716 | cefla s.c | Neowise | May 4, 2026 |
| K260009 | broncus medical | LungPoint Virtual Bronchoscopic Navigation (VBN) Software | April 24, 2026 |
| K254237 | clinicomp, intl | CCI PACS VIEWER (PACS-US-001) | April 23, 2026 |
| K253029 | mediott | RW-1 | March 31, 2026 |
| K253950 | avatar medical | Avatar Medical Vision | March 30, 2026 |
| K252195 | artiness | ARTICOR planner | March 27, 2026 |
| K253111 | good methods global | Aeka Imaging | March 13, 2026 |
| K260479 | boston scientific corporation | TheraSphere 360 Y-90 Management Platform | March 13, 2026 |