FDA 510(k)
FDA class 2
Substantially Equivalent
🇧🇪 Belgium
AGFA HealthCare Enterprise Imaging
K Number: K252199
·
Decision Oct 15, 2025
Classifications
1
FEI Numbers
599
Registration Numbers
599
Same Product Code
2271
Applicant Total
27
Review Days
93
Basic Information
- Device Name
- AGFA HealthCare Enterprise Imaging
- K Number
- K252199
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Agfa Healthcare N.V.
- Date Received
- July 14, 2025
- Decision Date
- October 15, 2025
- 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 Agfa Healthcare N.V.
| K Number | Device Name | ||
|---|---|---|---|
| K180589 | DR 800 with MUSICA Dynamic | Apr 5, 2018 | Substantially Equivalent |
| K172784 | DX-D Imaging Package | Oct 13, 2017 | Substantially Equivalent |
| K170434 | Enterprise Imaging XERO Viewer 8.1 | Jul 3, 2017 | Substantially Equivalent |
| K161368 | DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s) | Sep 22, 2016 | Substantially Equivalent |
| K161061 | IMPAX Volume Viewing 4.0 | Jun 22, 2016 | Substantially Equivalent |
| K152639 | DR 600 | Dec 11, 2015 | Substantially Equivalent |
| K143397 | ICIS View | Jun 1, 2015 | Substantially Equivalent |
| K142316 | IMPAX Agility | Jan 6, 2015 | Substantially Equivalent |
| K142184 | DX-D IMAGING PACKAGE | Oct 16, 2014 | Substantially Equivalent |
| K141602 | DX-D IMAGING PACKAGE | Sep 12, 2014 | Substantially Equivalent |