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Sign in to claim this brandIcad, Inc.
US
Last updated May 24, 2026
What Icad, Inc. makes
The company develops and manufactures software applications for radiology and diagnostic imaging, including DICOM-based processing tools for x-ray, CT, and mammography systems, as well as specialized diagnostic software like breast density assessment solutions. It also produces radiation shielding aprons and components for intraoperative and postoperative therapeutic x-ray systems, such as surface controllers, balloon applicator kits, vaginal applicators, and x-ray sources designed for targeted radiation therapy.
The portfolio includes devices classified under FDA regulations as Class I and Class II, with authorisation pathways including 510(k), PMA, and UDI submissions. These products are listed in the FDA’s regulatory databases, and the company operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- icadmed.com
- —
- —
- [email protected]
- Phone
- 1-866-280-2239
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 108870254
Catalogue (162)
Page 4 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ProFound Detection (V4.0) | K240417 | FDA 510(k) | Class II | Active |
| Axxent Electronic Brachytherapy System Model 110 XP 1200 | K153570 | FDA 510(k) | Class II | Active |
| Second Look Viewer | K042697 | FDA 510(k) | Class II | Active |
| PowerLook Density Assessment Software | K180125 | FDA 510(k) | Class II | Active |
| Icad Breast Interventional Planning Software, Model D70024 | K090223 | FDA 510(k) | Class II | Active |
| Icad Veralook Ctc Cad Software | K091529 | FDA 510(k) | Class II | Active |
| PowerLook Tomo Detection V2 Software | K182373 | FDA 510(k) | Class II | Active |
| Versavue Enterprise Suite | K121517 | FDA 510(k) | Class II | Active |
| PowerLook® Tomo Detection Software | P160009 | FDA PMA | Class II | Active |
| M-Vu Algorithm Engine | P100005 | FDA PMA | Class II | Active |
| Secondlook (sl) Cad | P010038 | FDA PMA | Class II | Active |
| Second Look Computer-Aided Detection System For Mammography | P010034 | FDA PMA | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (3)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Icad, Inc. has three recall records initiated between December 9, 2008, and January 21, 2015, all of which are marked as terminated. The reasons cited include software modules not being approved for the intended use and a potential device malfunction where the biopsy needle may fail to reach the target, potentially leading to mislocation if confirming radiographs are not properly evaluated.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jan 21, 2015 | Z-1243-2015 | — | terminated | A device malfunction may cause the biopsy needle to fail to reach the intended target. If location confirming radiographs are not taken and properly evaluated, biopsy site mislocation can result in non-target tissue being sampled rather than target tissue. May result in an incorrect diagnosis. |
| Dec 9, 2008 | Z-0654-2009 | — | terminated | Software modules not approved for this indication. |
| Dec 9, 2008 | Z-0653-2009 | — | terminated | Software modules not approved for this indication. |