ClariSIGMAM
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Basic Information
- Primary DI
- D-88000468SMM-13HQPS
- Basic UDI-DI Code
- B-88000468SMM-13HQPS
- Reference
- ClariSIGMAM
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 1
- Status
- On The Market
- Manufacturer
- ClariPi Inc.
Additional Description
ClariSIGMAM is a software application intended for use with compatible full field digital mammography systems. ClariSIGMAM calculates percent breast density defined as the ratio of fibroglandular tissue to total breast area estimates. ClariSIGMAM uses this numerical value to provide breast density group information (BI-RADS A+B as fatty and BI-RADS C+D as dense) to aid interpreting physicians in the assessment of breast tissue composition. ClariSIGMAM produces adjunctive information. It is not a diagnostic aid.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z11030692 | COMPUTED TOMOGRAPHS (CT) - MEDICAL DEVICE SOFTWARE |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 287306-2019-CE-KOR-NA-PS | DNV Product Assurance AS | Expired |
Available In Countries
Similar Devices
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