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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 3 of 4

Device	Model / Reference	Registries	Class	Status
PowerLook 11 PRO+, FRU	D4D0248	FDA UDI	Class I	Active
PowerLook PRO+ Hardware Platform GE, US	DSC018-04	FDA UDI	Class I	Active
PowerLook PRO with Tomo Detection, Upgrade, GE	V1.1	FDA UDI	Class II	Active
VeraLook CTC CAD	V1.1	FDA UDI	Class II	Active
HDR X-ray Source 2.2	720684	FDA UDI	Class II	Active
VeraLook CTC CAD	V1.0	FDA UDI	Class II	Active
VeraLook CTC CAD	V1.0	FDA UDI	Class II	Active
(10) Applicator End Cap, 10 mm	720297	FDA UDI	Class II	Active
xFlexShield	720744	FDA UDI	Class I	Active
Surface Applicator Cone, 35 mm	711109	FDA UDI	Class II	Active
PowerLook PRO+ 4GPU Tower Platform, US	DSC018-07	FDA UDI	Class I	Active
PowerLook PRO with Tomo Detection	V1.1	FDA UDI	Class II	Active
PowerLook AMP PRO, SLD, GE, ROW	V7.2	FDA UDI	Class II	Active
PowerLook AMP SLD GE OUS Direct	DSC010-12-EU	FDA UDI	Class II	Active
PowerLook Tomo Detection (ProFound AI)	V2	FDA UDI	Class II	Unknown
Surface Applicator Cone, 50 mm	711110	FDA UDI	Class II	Active
Powerlook PRO Hardware Upgrade, SLD	V7.2	FDA UDI	Class II	Active
PowerLook 10.1.1	D4D0231	FDA UDI	Class I	Active
Balloon Applicator Kit	720343	FDA UDI	Class II	Active
Packaged Cutout 27 mm, xFlex	720822	FDA UDI	Class I	Active
(10) Applicator End Cap, 20 mm	720298	FDA UDI	Class II	Active
PowerLook AMP SLD FRU	V7.2	FDA UDI	Class II	Active
Axxent Standard Controller	750050	FDA UDI	Class II	Active
FRU, PowerLook 10, Generic	D4D0222	FDA UDI	Class I	Active
PowerLook PRO Tomo Detection and SLD, GE	V1.1	FDA UDI	Class II	Active
PowerLook MammoAI Container - GE	1.0	FDA UDI	Class I	Active
DynaCAD	3.5	FDA UDI	Class II	Active
Testing	1.0	FDA UDI	Class I	Active
PowerLook PRO+ Rack-Mount, US	DSC033-01, DSC033-02, DSC033-03	FDA UDI	Class I	Active
Surface Applicator Set	710339	FDA UDI	Class II	Active
Balloon Applicator Kit	720332	FDA UDI	Class II	Active
ProFound AI 3.1	3.1	FDA UDI	Class I	Active
Balloon Applicator	720846	FDA UDI	Class II	Active
Surface Applicator Cone, 20 mm	711108	FDA UDI	Class II	Active
PowerLook AMP SLD GE US	V7.2	FDA UDI	Class II	Active
PowerLook PRO Tomo Detection and SLD, GE	V1.1	FDA UDI	Class II	Active
Vaginal Applicator, 35mm	720270	FDA UDI	Class II	Active
DynaLOC Breast Interventional Planning Software	3.5	FDA UDI	Class II	Active
PowerLook 11	11	FDA UDI	Class I	Active
Vaginal Applicator Set	710188	FDA UDI	Class II	Active
PowerLook PRO Tomo Detection and SLD, GE	V1.1	FDA UDI	Class II	Active
Powerlook PRO with SLD, GE, US	V7.2	FDA UDI	Class II	Active
PowerLook AMP SLD Fuji OUS	DSC010-04-EU	FDA UDI	Class II	Active
PowerLook PRO+ Hardware Platform GE	DSC018-02	FDA UDI	Class I	Active
Axxent Cervical Applicator	K141343	FDA 510(k)	Class II	Active
PowerLook Density Assessment V4.0	K211506	FDA 510(k)	Class II	Active
Xoft Axxent Electronic Brachytherapy System Model 110	K122951	FDA 510(k)	Class II	Active
Xoft Axxent Cervical Applicators	K123442	FDA 510(k)	Class II	Active
ProFound AI Software V2.1	K191994	FDA 510(k)	Class II	Active
ProFound AI Software V3.0	K203822	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

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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.