Facility

ICAD INC.

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

2inspections · worst NAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3026970882
Establishment type	Manufacture Medical Device
Location	2 Townsend West Nashua, NH, US 03063
Registration status	Active · expires 2026
Parent company	iCAD INC. (owner-operator 9054868)
Brand names	ProFound AI V2.1

Activity by year

Recalls (1)
Inspections (2)

Devices registered here (1)

Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
Product code QDQ (opens in a new tab) · Class II · Radiology · 21 CFR 892.2090

Recalls & enforcement

Class IITerminated2015-01-21
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 incorr…

FDA inspections (2)

NAI2021-05-25
No Action Indicated · Compliance: Devices
NAI2017-11-09
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by iCAD INC.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “ICAD INC. (FEI 3026970882) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3026970882-icad-inc/

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