FDA 510(k)
Premarket notification pathway for substantial equivalence where applicable. Prefer “FDA cleared” language for 510(k) products.
In-vitro diagnostics and care-setting systems
Hologic systems planned around laboratory and care workflow
Compare analyzer throughput, sample handling, detector maintenance, home-care capacity, LIS connectivity, and service assumptions before a facility commits to a configuration.
Regulatory and quality references
Credentials that procurement teams expect to see early
Use these as diligence anchors. Exact market status remains product-, revision-, and geography-specific.
CE MDR / IVDR
European conformity references under MDR 2017/745 and IVDR 2017/746 for covered device families.
ISO 13485
Medical device quality management system framework for design controls, CAPA, and supplier oversight.
IEC 60601
Medical electrical equipment safety and essential performance expectations for applicable powered systems.
Care-setting applications
Start with the clinical environment, not a SKU list
Representative decision prompts
Three questions that reshape a Hologic brief
These are planning scenarios, not named-hospital endorsements or guaranteed outcomes.
“Can the detector maintenance cycle and spare-parts SLA support a five-day mammography schedule without cascading cancellations?”
Imaging operations director
Community hospital scenario
“What coefficient of variation and method-comparison package must we complete before patient reporting on a new immunoassay menu?”
Laboratory quality manager
Core-lab verification scenario
“Does the home-care lift and bed package include documented patient weight capacity, battery runtime, and service training for our agency?”
Home health procurement lead
Agency fleet scenario
Make four planning dimensions explicit before configuration
Volume
hourly arrival and peak profile
Menu
assays, modalities, care SKUs
Quality
QC, calibration, LOD / CV limits
Support
uptime, parts, MTTR escalation
Request a clinical specialist consult
Bring the specimen volume, detector fleet, or care roster
We will structure a product, service, and local verification conversation without treating brochure numbers as guaranteed site performance.
- Model-specific IFU and intended-use review
- Service coverage and spare-parts assumptions
- Connectivity expectations for HL7 / DICOM where used
- Acceptance criteria for local method verification