FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LungPoint Virtual Bronchoscopic Navigation (VBN) Software
K Number: K260009
·
Decision Apr 24, 2026
Classifications
1
FEI Numbers
599
Registration Numbers
599
Same Product Code
2271
Applicant Total
7
Review Days
112
Basic Information
- Device Name
- LungPoint Virtual Bronchoscopic Navigation (VBN) Software
- K Number
- K260009
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Broncus Medical, Inc.
- Date Received
- January 2, 2026
- Decision Date
- April 24, 2026
- Product Code
- LLZ
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LLZ), ordered by most recent decision date.
2D Hip Planning Software
FDA 510(k)
FDA Class 2
·Radiology
CustoMED Viewer
FDA 510(k)
FDA Class 2
·Radiology
Helion Viewer Suite
FDA 510(k)
FDA Class 2
·Radiology
CMN Capillary Function with Virtual Expert for MRI, CT and CBCT
FDA 510(k)
FDA Class 2
·Radiology
SubtleHD-PET (1.x)
FDA 510(k)
FDA Class 2
·Radiology
HipGuide (V 1.0.0.0)
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Broncus Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K232601 | BroncTru Transbronchial Access Tool | May 31, 2024 | Substantially Equivalent |
| K232038 | BioStar Single Use Transbronchial Aspiration Needle | Apr 26, 2024 | Substantially Equivalent |
| K200702 | EasyPath RF Introducer Sheath | Jan 14, 2021 | Substantially Equivalent |
| K183240 | Empower RF Catheter | Feb 22, 2019 | Substantially Equivalent |
| K133385 | LUNGPOINT ATV PLANNING AND NAVIGATION SOFTWARE | Feb 26, 2014 | Substantially Equivalent |
| K131234 | LUNGPOINT TOOLS (LUNGPOINT SHEATH, LUNGPOINT DILATION BALLOON) | Oct 15, 2013 | Substantially Equivalent |