Company ยท US
Icad, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2004 to 2024. Name variants (Inc, Corp, punctuation) are merged.
14510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LLZ | System, Image Processing, Radiological | 5 |
| QDQ | Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer | 4 |
| JAD | System, Therapeutic, X-Ray | 3 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 2 |
| JAK | System, X-Ray, Tomography, Computed | 1 |
| JAQ | System, Applicator, Radionuclide, Remote-Controlled | 1 |
| QIH | Automated Radiological Image Processing Software | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 8, 2024 | K240417 | ProFound Detection (V4.0) Icad, Inc. | QDQ |
| Jul 12, 2021 | K211506 | PowerLook Density Assessment V4.0 Icad, Inc. | QIH |
| Mar 12, 2021 | K203822 | ProFound AI Software V3.0 Icad, Inc. | QDQ |
| Oct 4, 2019 | K191994 | ProFound AI Software V2.1 Icad, Inc. | QDQ |
| Dec 6, 2018 | K182373 | PowerLook Tomo Detection V2 Software Icad, Inc. | QDQ |
| Apr 5, 2018 | K180125 | PowerLook Density Assessment Software Icad, Inc. | LLZ |
| Feb 25, 2016 | K153570 | Axxent Electronic Brachytherapy System Model 110 XP 1200 Icad, Inc. | JAD |
| Sep 5, 2014 | K141343 | AXXENT CERVICAL APPLICATOR Icad, Inc. | JAD |
| Feb 27, 2013 | K123442 | XOFT AXXENT CERVICAL APPLICATORS Icad, Inc. | JAQ |
| Jan 17, 2013 | K122951 | XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM MODEL 110 Icad, Inc. | JAD |
| Jul 20, 2012 | K121517 | VERSAVUE ENTERPRISE SUITE Icad, Inc. | LLZ |
| Aug 4, 2010 | K091529 | ICAD VERALOOK CTC CAD SOFTWARE Icad, Inc. | JAK |
| Mar 31, 2009 | K090223 | ICAD BREAST INTERVENTIONAL PLANNING SOFTWARE, MODEL D70024 Icad, Inc. | LLZ |
| Nov 19, 2004 | K042697 | SECOND LOOK VIEWER Icad, Inc. | LLZ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 4, 2015 | iCAD, Inc. DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2 Terminated |
LLZ | K090223 |
| Jan 27, 2009 | iCAD, Inc. CAD SCIENCES LLC 3TP PrecisionPointTM Software, for biopsy guidance. Terminated |
LNH | None listed |
| Jan 27, 2009 | iCAD, Inc. CAD SCIENCES LLC 3TP TheraMapTM Software, for oncology treatment planning, assessment and monitoring of the patient response. Terminated |
LNH | K031350 K050862 |