Icad Breast Interventional Planning Software, Model D70024
FDA 510(k)Class II (US FDA 510(k))
by Icad, Inc.
Identifiers
- 510(k) Number
- K090223 FDA 510(k)
- FDA Product Code
- LLZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Icad Breast Interventional Planning Software, Model D70024 is a DICOM 3.0 compliant post-processing tool for MRI data. It assists radiologists in planning MR-guided breast interventional procedures, such as biopsies, by calculating optimal positioning, location, and depth based on MRI datasets, user-defined regions of interest, and fiducial marker coordinates.
This software is supplied as a medical device for use in radiology settings. It has received FDA 510(k) clearance under K-number K090223.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ICAD BREAST INTERVENTIONAL PLANNING SOFTWARE, MODEL D70024, Icad Breast Interventional Planning Software, D70024, ICAD BREAST INTERVENTIONAL PLANNING SOFTWARE, MODEL D70024
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K090223 | Class II | Active |
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Manufacturer
- Manufacturer
- Icad, Inc.
Sources (1)
- FDA 510(k) K090223 24 fields · synced Sep 21, 2026