Manufacturer's Devices - Hologic Inc.
Address:
36 Apple Ridge Road
Danbury
Connecticut 6810
United States
Authorised Representative/ UK Responsible Person
Name: Hologic Ltd.
Address:
Heron House 6 The Oaks Business Park Crewe Road Wythenshawe
Manchester
Lancashire M23 9HZ
England United Kingdom
| Code/Term |
|
Type |
| Radiology DICOM image processing application software | Radiology DICOM image processing application software | Class I
|
| Radiology PACS software | Radiology PACS software | Class I
|
| Tissue specimen x-ray system IVD | Tissue specimen x-ray system IVD | Class I
|
| Stationary mammographic x-ray system digital | Stationary mammographic x-ray system digital | Class IIb
|
| Mammographic stereotactic biopsy system | Mammographic stereotactic biopsy system | Class IIb
|
| Bone absorptiometric x-ray system dual-energy | Bone absorptiometric x-ray system dual-energy | Class IIb
|
| Mobile general-purpose fluoroscopic x-ray system digital | Mobile general-purpose fluoroscopic x-ray system digital | Class IIb
|
| Radiology PACS software | Radiology PACS software | Class IIa
|
| Radiology PACS software | Radiology PACS software | Class I
|
| Radiological breast positioner non-wearable | Radiological breast positioner non-wearable | Class I
|
| Mammographic x-ray system compression paddle | Mammographic x-ray system compression paddle | Class I
|
| Radiology DICOM image processing application software | Radiology DICOM image processing application software | Class I
|
| Mammographic x-ray system compression paddle | Mammographic x-ray system compression paddle | Class I
|
| Radiological breast positioner non-wearable | Radiological breast positioner non-wearable | Class I
|