Icad, Inc.
United StatesFDA applicant, unverified
Icad, Inc. is a medical device manufacturer, with 163 devices listed in FDA GUDID, FDA 510(k) and FDA PMA (FDA Class II and I) and 3 FDA recalls as of 13 Nov 2026.
- Devices
- 163
- FDA recalls
- 3
Registry facts
- Registries
- FDA GUDID 145
- FDA 510(k) 14
- FDA PMA 4
- Device classes
- FDA Class II 106
- FDA Class I 57
- FDA recalls
- Identifiers
- DUNS 108870254
At a glance
Market reach
- United States
- FDA recalls
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.
Catalogue
Search and filter all 163 devicesShowing 1-50 of 163
Company details
- DUNS number
- 108870254
- Phone
- 1-866-280-2239
FDA recalls
FDA recall records list 3 recalls initiated by Icad, Inc., the earliest on 2008-12-09 and the most recent on 2015-01-21. By recorded status: 3 terminated. The reasons filed fall into these groups: software or firmware. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2015
- 21 Jan 2015 Z-1243-2015 Class II 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.
Full distribution text
- 21 Jan 2015 Z-1243-2015 Class II 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.
2008
- 9 Dec 2008 Z-0653-2009 Unclassified (pre-2012) Terminated Software modules not approved for this indication.
- 9 Dec 2008 Z-0654-2009 Unclassified (pre-2012) Terminated Software modules not approved for this indication.
Frequently asked questions
How many devices does Icad, Inc. have in the registry?
The registry currently lists 163 devices for Icad, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Icad, Inc.'s devices?
Among its 50 most recently registered devices, Icad, Inc. has devices listed in FDA GUDID (50 devices).
What risk classes do Icad, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Icad, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Icad, Inc.?
FDA recall records list 3 recalls initiated by Icad, Inc., the most recent initiated on 21 Jan 2015. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Icad, Inc. in the registry?
The most recently registered devices listed for Icad, Inc. include ProFound Detection 4.0, iReveal Breast Density Assessment V2.1, Axxent Surface Controller 750850 and Powerlook PRO with SLD, FRU V7.2.