iCAD, Inc.
Nashua, NH, US
ICAD INC. appears in FDA device records in Nashua, NH. FDA records list 13 510(k) clearances between and , 31 PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 13 510(k) clearances for iCAD, Inc. between 2009 and 2024. The busiest year on record is 2013, with 2. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2009 | 1 |
| 2010 | 1 |
| 2012 | 1 |
| 2013 | 2 |
| 2014 | 1 |
| 2016 | 1 |
| 2018 | 2 |
| 2019 | 1 |
| 2021 | 2 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K240417 | ProFound Detection (V4.0) | QDQ | Substantially Equivalent | |
| K211506 | PowerLook Density Assessment V4.0 | QIH | Substantially Equivalent | |
| K203822 | ProFound AI Software V3.0 | QDQ | Substantially Equivalent | |
| K191994 | ProFound AI Software V2.1 | QDQ | Substantially Equivalent | |
| K182373 | PowerLook Tomo Detection V2 Software | QDQ | Substantially Equivalent | |
| K180125 | PowerLook Density Assessment Software | LLZ | Substantially Equivalent | |
| K153570 | Axxent Electronic Brachytherapy System Model 110 XP 1200 | JAD | Substantially Equivalent | |
| K141343 | AXXENT CERVICAL APPLICATOR | JAD | Substantially Equivalent | |
| K123442 | XOFT AXXENT CERVICAL APPLICATORS | JAQ | Substantially Equivalent | |
| K122951 | XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM MODEL 110 | JAD | Substantially Equivalent | |
| K121517 | VERSAVUE ENTERPRISE SUITE | LLZ | Substantially Equivalent | |
| K091529 | ICAD VERALOOK CTC CAD SOFTWARE | JAK | Substantially Equivalent | |
| K090223 | ICAD BREAST INTERVENTIONAL PLANNING SOFTWARE, MODEL D70024 | LLZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3026970882 | 3026970882 | ICAD INC. | 2 Townsend West, Nashua, NH 03063 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- MYNAnalyzer, Medical Image
- QIHAutomated Radiological Image Processing Software
- LMADigitizer, Image, Radiological
- QDQRadiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
- JAQSystem, Applicator, Radionuclide, Remote-Controlled
- LMDSystem, Digital Image Communications, Radiological
- LLZSystem, Image Processing, Radiological
- JADSystem, Therapeutic, X-Ray
- JAKSystem, X-Ray, Tomography, Computed
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1243-2015 | DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2 | 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. | Class II | Terminated | |
| Z-0654-2009 | CAD SCIENCES LLC 3TP PrecisionPointTM Software, for biopsy guidance. | Software modules not approved for this indication. | Terminated | ||
| Z-0653-2009 | CAD SCIENCES LLC 3TP TheraMapTM Software, for oncology treatment planning, assessment and monitoring of the patient response. | Software modules not approved for this indication. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain