Is this your brand? Sign in to claim ownership.

Icad, Inc.

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
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 1-866-280-2239
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 108870254

Catalogue (162)

Page 1 of 4

Device	Model / Reference	Registries	Class	Status
iReveal Breast Density Assessment	V2.1	FDA UDI	Class II	Active
Axxent Surface Controller	750850	FDA UDI	Class II	Active
Powerlook PRO with SLD, FRU	V7.2	FDA UDI	Class II	Active
PowerLook PRO+ Rack-Mount, US	DSC018-06	FDA UDI	Class I	Active
Packaged Cutout 17.5 mm, xFlex	720819	FDA UDI	Class I	Active
PowerLook AMP SLD Siemens OUS	DSC010-03-EU	FDA UDI	Class II	Active
PowerLook Density Assessment V4.0	4.0	FDA UDI	Class I	Active
PowerLook AMP SLD Siemens	V7.2	FDA UDI	Class II	Active
Packaged Cutout 33mm, xFlex	720824	FDA UDI	Class I	Active
PowerLook Al Mammo Container - Arterys v 1.2.0	DSC028-02	FDA UDI	Class I	Active
Balloon Applicator Kit	720331	FDA UDI	Class II	Active
Vaginal Applicator, 20mm	720267	FDA UDI	Class II	Active
Cervical Applicator Set, Bundle 2	710855	FDA UDI	Class II	Active
Surface Applicator Cone, 10 mm	711107	FDA UDI	Class II	Active
ProFound AI	2.1	FDA UDI	Class II	Active
Balloon Applicator	720847	FDA UDI	Class II	Active
PowerLook AMP SLD GE Direct	V7.2	FDA UDI	Class II	Active
ProFound AI 3.1	3.1	FDA UDI	Class I	Active
PowerLook MammoAI Container - Arterys	DSC028-01	FDA UDI	Class I	Active
PowerLook FRU	D4D0211	FDA UDI	Class I	Active
PowerLook PRO+, OUS	DSC030-01, DSC030-02, DSC030-03	FDA UDI	Class I	Active
PowerLook PRO+ 4GPU Tower Platform, OUS	DSC032-01, DSC032-02, DSC032-03	FDA UDI	Class I	Active
PowerLook AMP with Density Assessment GE OUS	DSC012-03	FDA UDI	Class II	Active
PowerLook AMP SLD Agfa CR	DSC010-09	FDA UDI	Class II	Active
(10) Applicator End Cap, 35 mm	720296	FDA UDI	Class II	Active
PowerLook AMP SLD Philips	V7.2	FDA UDI	Class II	Active
PowerLook PRO+ Rack-Mount, FRU	D4D0212	FDA UDI	Class I	Active
PowerLook AMP SLD GE OUS	DSC010-01-EU	FDA UDI	Class II	Active
PowerLook Density Assessment V3.4	V3.4	FDA UDI	Class II	Active
Vaginal Applicator, 25mm	720268	FDA UDI	Class II	Active
PowerLook	9.1	FDA UDI	Class I	Active
Packaged Cutout 25 mm, xFlex	720821	FDA UDI	Class I	Active
PowerLook PRO+ 4GPU Tower Platform, OUS	DSC018-08	FDA UDI	Class I	Active
FRU, PowerLook 10 PRO+	D4D0223	FDA UDI	Class I	Active
Vaginal Applicator Set with Base and Clamp	720216	FDA UDI	Class II	Active
PowerLook 10 PRO+, Tower US	DSC011-01-US	FDA UDI	Class I	Active
PowerLook 10 PRO+, Rack Mount, US	DSC011-03-US	FDA UDI	Class I	Active
Rigid Shield 7 cm	710710	FDA UDI	Class II	Active
PowerLook to PowerLook PRO Upgrade, US	V7.2	FDA UDI	Class II	Active
Powerlook PRO Hardware Upgrade, SLD	V7.2	FDA UDI	Class II	Active
PowerLook 11.2	Version 11.2	FDA UDI	Class I	Active
PowerLook AMP with Density Assessment GE US	DSC012-02	FDA UDI	Class II	Active
PowerLook PRO+ Rack-Mount, OUS	DSC034-01, DSC034-02, DSC034-03	FDA UDI	Class I	Active
PowerLook 10 PRO+	V10	FDA UDI	Class I	Active
PowerLook 10.1	10.1	FDA UDI	Class I	Active
SecondLook Digital (SLD)	V7.2	FDA UDI	Class II	Active
Balloon Applicator	720849	FDA UDI	Class II	Active
Packaged Cutout 15 mm, xFlex	720818	FDA UDI	Class I	Active
Rigid Shield 6 cm	710709	FDA UDI	Class II	Active
PowerLook AMP SLD FRU GE	V7.2	FDA UDI	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.