LLZ — System, Image Processing, Radiological Class II
FDA Device Classification
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 |
|---|
| 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 |
| K251964 | materialise | Mimics Thoracic Planner | March 12, 2026 |
| K253486 | skia | SKIA-Head (Model: SKIA-ST00) | February 23, 2026 |
| K260205 | as software | AS Software Version Asera | February 19, 2026 |
| K251577 | augmented reality software s.l | LAIA XR | February 6, 2026 |
| K253927 | live medica | LiveMedica Enterprise PACS | February 6, 2026 |
| K253639 | ge healthcare | View | January 8, 2026 |