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 |
|---|
| K260479 | boston scientific corporation | TheraSphere 360 Y-90 Management Platform | March 13, 2026 |
| K253111 | good methods global | Aeka Imaging | March 13, 2026 |
| K251964 | materialise | Mimics Thoracic Planner | March 12, 2026 |
| K253551 | depuy ireland uc | VELYS Hip Navigation | March 6, 2026 |
| K253486 | skia | SKIA-Head (Model: SKIA-ST00) | February 23, 2026 |
| K260205 | as software | AS Software Version Asera | February 19, 2026 |
| K253927 | live medica | LiveMedica Enterprise PACS | February 6, 2026 |
| K251577 | augmented reality software s.l | LAIA XR | February 6, 2026 |
| K253639 | ge healthcare | View | January 8, 2026 |
| K253784 | singular health pty | 3DICOM MD Cloud | January 8, 2026 |
| K253008 | maihub | maiLink | January 5, 2026 |
| K251883 | mim software | MIM LesionID Pro | December 11, 2025 |
| K251880 | archy dental | Archy Dental Imaging | November 21, 2025 |
| K253495 | siemens healthineers | syngo.MR Applications (VB80) | November 20, 2025 |
| K251410 | vieworks co | VXvue | November 4, 2025 |
| K251532 | mighty oak medical | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | November 3, 2025 |
| K252547 | boston scientific corporation | TheraSphere 360 Y-90 Management Platform | October 28, 2025 |
| K251030 | sirona medical | Sirona Advanced Imaging Suite | October 22, 2025 |
| K252476 | brainlab | Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements View | October 16, 2025 |
| K252199 | agfa healthcare n.v | AGFA HealthCare Enterprise Imaging | October 15, 2025 |