Axial3D Cloud Segmentation Service
Axial Medical Printing Limited · Radiology
Open FDA's page for this record- Third party flag
- N
- City
- Belfast
- Advisory committee description
- Radiology
- Address 1
- 17a Ormeau Ave.
- Statement or summary
- Summary
- Product code
- LLZ
- Zip code
- BT2 8HD
- Applicant
- Axial Medical Printing Limited
- Decision date
- 2024-01-24
- Decision code
- SESE
- Country code
- GB
- Device name
- Axial3D Cloud Segmentation Service
- Advisory committee
- RA
- Contact
- Jenna McGarry
- K number
- K231607
- Date received
- 2023-06-01
- Review advisory committee
- RA
- Postal code
- BT2 8HD
- Decision description
- Substantially Equivalent
- Clearance type
- Special
- Harmonized identifiers (openFDA)
- Device name
- System, Image Processing, Radiological
- Medical specialty description
- Radiology
- Regulation number
- 892.2050
- Device class
- 2
- Registration number
- 3001052305, 3005406110, 3017545364, 3005172103, 9617978, 3004706313, 3008487708, 1226544, 3009341091, 3044776706, 3010656400, 3038189169, 3007362683, 3007993775, 1061158, 3014232555, 3003757027, 3014991167, 9617592, 3013634985, 3023217364, 1054415, 3013535906, 3026047529, 3019878658, 3005225421, 3030655434, 3009156722, 3010445368, 8020825, 3011676026, 3008364043, 3045521711, 3014635169, 2954921, 9615439, 3011015597, 3003989064, 3035371452, 3019544554 +603 more
- FEI number
- 3001052305, 3005406110, 3017545364, 3005172103, 3004706313, 3008487708, 3009341091, 3044776706, 3002808188, 3010656400, 3038189169, 3007362683, 3007993775, 3014232555, 3003757027, 3014991167, 3013634985, 3023217364, 3013535906, 3026047529, 3019878658, 3005225421, 3030655434, 3009156722, 3010445368, 3011676026, 3008364043, 3045521711, 3014635169, 3011015597, 3003989064, 3035371452, 3019544554, 3008548323, 3014269683, 3002821504, 2126677, 3002619595, 3010684280, 3003861317 +603 more
