Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3026970882

FEI Number

3026970882

Entity Name

ICAD INC.

City/State/Country

Nashua, NH, US

Establishment Address

2 Townsend West, Suite 6, Nashua, NH 03063, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

iCAD INC. (Owner Number: 9054868)

Owner / Operator Contact Address

2 Townsend West, Suite 6, --, Nashua, NH 03063, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K132742

PMA Number

N/A

All Registered Proprietary Names

ProFound AI ProFound AI V3 ProFound Density PowerLook Density Assessment V4 PowerLook Density Assessment 3D PowerLook AMP SecondLook Digital Howtek 960 VeraLook Colon CAD ProFound Detection (V4) ProFound Detection ProFound Detection (PFD) PowerLook Tomo Detection ProFound AI PowerLook Tomo Detection V2 ProFound AI V2.1 PowerLook Density Assessment 2D PowerLook Density Assessment

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QDQ	Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer	Radiology	Class 2	892.2090	2022-05-25
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2022-05-25
LMD	System, Digital Image Communications, Radiological	Radiology	Class 1	892.2020	2011-11-08
MYN	Analyzer, Medical Image	Radiology	Class 2	892.2070	2007-12-05
LMA	Digitizer, Image, Radiological	Radiology	Class 2	892.2030	2008-04-24
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2010-08-19
QDQ	Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer	Radiology	Class 2	892.2090	2025-04-14
MYN	Analyzer, Medical Image	Radiology	Class 2	892.2070	2017-03-31
QDQ	Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer	Radiology	Class 2	892.2090	2018-12-11
QDQ	Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer	Radiology	Class 2	892.2090	2019-10-09
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2015-06-09

Official Correspondent

B. Nathan Hunt

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

iCAD INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K242270	Orthofix Srl	OrthoNext Platform System	2024-12-19
K261713	FUJIFILM Healthcare Americas Corporation	Synapse PACS (7.6.0)	2026-06-18
K243647	FUJIFILM Healthcare Americas Corporation	Synapse PACS (7.5)	2025-06-30
K243523	Siemens Medical Solutions USA, Inc.	NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime	2025-02-12
K781431	General Electric Co.	ELECTRIC CT/T OPERATOR DISPLAY CONSOLE	1978-09-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2011	GE Medical Systems, LLC	2	HiSpeed X/i Computed Tomography operator consoles with the Model Number 2153675 and 2247802. The expected usage of this product is to generate head and whole body CT images of human subjects.
Z-0009-2017	Philips Medical Systems	2	Brilliance 64 CT Model Number 728231 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0010-2017	Philips Medical Systems	2	Ingenuity Core Model Number 728321 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0011-2017	Philips Medical Systems	2	Ingenuity Core 128 Model Number 728323 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0012-2017	Philips Medical Systems	2	Ingenuity CT Model Number 728326 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

Similar Registrations

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3015173173	SCREENPOINT MEDICAL	Nijmegen Gelderland, NL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3026970882. Last updated year: 2026. Please use registration number 3026970882 when referencing this establishment in official correspondence.