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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 2 of 4

Device	Model / Reference	Registries	Class	Status
PowerLook PRO+ Hardware Platform	DSC018-01	FDA UDI	Class I	Active
HDR X-ray Source 2.2	720684-02	FDA UDI	Class II	Active
PowerLook AMP SLD Planmed	DSC010-08	FDA UDI	Class II	Active
PowerLook Cloud 1.0	DSC038-01	FDA UDI	Class I	Active
Rigid Shield 4 cm	710707	FDA UDI	Class II	Active
PowerLook 10 PRO+, Tower OUS	DSC011-02-OUS	FDA UDI	Class I	Active
(10) Applicator End Cap, 50 mm	720299	FDA UDI	Class II	Active
HDR X-ray Source 2.2	720697	FDA UDI	Class II	Active
PowerLook PRO Tomo Detection FRU	V1.1	FDA UDI	Class II	Active
Rigid Shield 5 cm	710708	FDA UDI	Class II	Active
PowerLook AMP PRO with SecondLook Digital	V7.2	FDA UDI	Class II	Active
Packaged Cutout set, xFlex	720825	FDA UDI	Class I	Active
Packaged Cutout 22.2 mm, xFlex	720820	FDA UDI	Class I	Active
PowerLook 11.1	11.1	FDA UDI	Class I	Active
PowerLook Tomo Detection Software	V1.1	FDA UDI	Class II	Active
PowerLook AMP SLD Fuji	V7.2	FDA UDI	Class II	Active
PowerLook 11.3	Version 11.3	FDA UDI	Class I	Active
Balloon Applicator	720848	FDA UDI	Class II	Active
VeraLook CTC CAD	V1.0	FDA UDI	Class II	Active
PowerLook Al Mammo Container- Ferrum v1.0.0	DSC037-01	FDA UDI	Class I	Active
Cervical Applicator Set, Bundle 1	710850	FDA UDI	Class II	Active
PowerLook PRO+ Rack-Mount, OUS	DSC018-05	FDA UDI	Class I	Active
PowerLook Al Mammo Container - Radiology Partners v1.0.0	DSC035-01	FDA UDI	Class I	Active
Axxent Radiation Shield - Rigid	710644	FDA UDI	Class II	Active
Surface Applicator Set Bundle 1	720314	FDA UDI	Class II	Active
PowerLook Tomo Detection and SecondLook Digital License	V1.1	FDA UDI	Class II	Active
PowerLook AMP SLD Giotto	DSC010-06	FDA UDI	Class II	Active
Vaginal Applicator, 30mm	720269	FDA UDI	Class II	Active
PowerLook AMP PRO, SLD, GE, ROW	V7.2	FDA UDI	Class II	Active
Flexishield Radiation Absorber	720772	FDA UDI	Class I	Active
Balloon Applicator Kit	720342	FDA UDI	Class II	Active
Packaged Cutout 30mm, xFlex	720823	FDA UDI	Class I	Active
PowerLook PRO+ 4GPU Tower Platform, US	DSC031-01, DSC031-02, DSC031-03	FDA UDI	Class I	Active
PowerLook Al Mammo Container- GE v1.1.0	DSC027-02	FDA UDI	Class I	Active
iReveal with PowerLook AMP	V2.1	FDA UDI	Class II	Active
PowerLook AMP SLD Hologic OUS	DSC010-05-EU	FDA UDI	Class II	Active
Packaged Cutout 12.7 mm, xFlex	720817	FDA UDI	Class I	Active
PowerLook PRO+ 4GPU Tower Upgrade, US	DSC018-07-UP	FDA UDI	Class I	Active
PowerLook AMP SLD Philips OUS	DSC010-07-EU	FDA UDI	Class II	Active
PowerLook 10 PRO+, Rack Mount, OUS	DSC011-04-OUS	FDA UDI	Class I	Active
PowerLook	V9	FDA UDI	Class I	Unknown
PowerLook PRO+ 2GPU Tower Platform, US	DSC029-01, DSC029-02, DSC029-03	FDA UDI	Class I	Active
PowerLook AI Mammo Container 1.0.0 Blackford	DSC036-01	FDA UDI	Class I	Active
PowerLook MammoAI Container - Sectra	DSC026-01	FDA UDI	Class I	Active
ProFound AI V3.0	3.0	FDA UDI	Class II	Active
Rigid Shield 3 cm	710706	FDA UDI	Class II	Active
Testing	2.0	FDA UDI	Class I	Unknown
Powerlook PRO Hardware Upgrade, SLD	V7.2	FDA UDI	Class II	Active
PowerLook AMP SLD Hologic	V7.2	FDA UDI	Class II	Active
Cervical Applicator Set	710746	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

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Notified Bodies

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Authorities

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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.