Data / Medical devices / United States / Icad Inc.
Icad Inc.: FDA-registered device maker in Nashua, NH, United States, 9 510(k) clearances and 2 PMA approvals
Icad Inc. is registered with the FDA (registration 3026970882) in Nashua, NH, United States. It lists 7 device types. The FDA files 9 510(k) clearances and 2 PMA approvals under its listings, the newest dated November 8, 2024. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3026970882
- Address
- 2 Townsend West Suite 6, Nashua, NH, United States, 03063
- Owner or operator
- iCAD INC. (9054868)
- Roles
- Manufacturer
- First device listed
- December 5, 2007
- Registered through
- 2026
- Brand names listed
- Howtek 960, PowerLook AMP, PowerLook Breast Assessment v3.4, PowerLook Density Assessment, PowerLook Density Assessment 2D, PowerLook Density Assessment 3D, PowerLook Density Assessment V4, PowerLook Tomo Detection and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Medical Image | MYN | 2 | Manufacturer | accessdata.fda.gov |
| Automated Radiological Image Processing Software | QIH | 2 | Manufacturer | accessdata.fda.gov |
| Digitizer, Image, Radiological | LMA | 2 | Manufacturer | accessdata.fda.gov |
| Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer | QDQ | 2 | Manufacturer | accessdata.fda.gov |
| System, Digital Image Communications, Radiological | LMD | 1 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Tomography, Computed | JAK | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 8, 2024 | K240417 | ProFound Detection (V4.0) | QDQ | Substantially Equivalent | Icad, Inc. | accessdata.fda.gov |
| July 12, 2021 | K211506 | PowerLook Density Assessment V4.0 | QIH | Substantially Equivalent | Icad, Inc. | accessdata.fda.gov |
| March 12, 2021 | K203822 | ProFound AI Software V3.0 | QDQ | Substantially Equivalent | Icad, Inc. | accessdata.fda.gov |
| October 4, 2019 | K191994 | ProFound AI Software V2.1 | QDQ | Substantially Equivalent | Icad, Inc. | accessdata.fda.gov |
| December 6, 2018 | K182373 | PowerLook Tomo Detection V2 Software | QDQ | Substantially Equivalent | Icad, Inc. | accessdata.fda.gov |
| April 5, 2018 | K180125 | PowerLook Density Assessment Software | LLZ | Substantially Equivalent | Icad, Inc. | accessdata.fda.gov |
| December 3, 2013 | K132742 | M-VU BREAST DENSITY | LLZ | Substantially Equivalent | Vucomp, Inc. | accessdata.fda.gov |
| August 4, 2010 | K091529 | ICAD VERALOOK CTC CAD SOFTWARE | JAK | Substantially Equivalent | Icad, Inc. | accessdata.fda.gov |
| May 20, 1997 | K970908 | HOWTEK 960 | LMA | Substantially Equivalent | Howtek, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| March 24, 2017 | P160009 | PowerLook® Tomo Detection Software | MYN | 0 | March 24, 2017 | accessdata.fda.gov |
| January 15, 2002 | P010038 | SECOND LOOK | MYN | 16 | June 19, 2013 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 21, 2015 | 70464 | Class II | Terminated | 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. | accessdata.fda.gov |
| December 9, 2008 | 50503 | Not yet classified | Terminated | CAD SCIENCES LLC 3TP TheraMapTM Software, for oncology treatment planning, assessment and monitoring of the patient response. | Software modules not approved for this indication. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Digital Image Communications, Radiological
- All makers of Automated Radiological Image Processing Software
- All makers of Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
- All makers of Digitizer, Image, Radiological
- All makers of System, X-Ray, Tomography, Computed
- All makers of System, Image Processing, Radiological
Updated November 8, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.