# Icad, Inc.

- Location (FDA's records): Nashua, NH
- FDA decisions: 18 (2002–2024): 14 510(k) clearances and 4 original PMA approvals
- Product codes: MYN (4), QDQ (4), LLZ (4), JAD (3), JAQ (1), QIH (1), JAK (1)
- 510(k) review time since 2016: median 76 days, against 139 for FDA's reviews in the same codes and years (3 of 4 faster)
- Predicates its devices cite: 16 (5 its own); citations of its devices by later devices: 14 (5 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Xoft, Inc.: 1 (https://510kreport.com/company/xoft)
- Varian Medical Systems, Inc.: 1 (https://510kreport.com/company/varian-medical-systems)
- Vucomp, Inc.: 1 (https://510kreport.com/company/vucomp)
- Matakina Technologies Limited: 1 (https://510kreport.com/company/matakina-technologies)
- Imagen Technologies, Inc.: 1 (https://510kreport.com/company/imagen-technologies)
- Mick Radio-Nuclear Instruments, Inc.: 1 (https://510kreport.com/company/mick-radio-nuclear-instruments)
- Medicsight: 1 (https://510kreport.com/company/medicsight)
- Siemens AG Medical Solutions: 1 (https://510kreport.com/company/siemens-ag-medical-solutions)

## Firms that cite its devices most
- Eigen: 2 (https://510kreport.com/company/eigen)
- Nucletron Corp.: 1 (https://510kreport.com/company/nucletron)
- Visage Imaging GmbH: 1 (https://510kreport.com/company/visage-imaging)
- R2 Technology, Inc.: 1 (https://510kreport.com/company/r2-technology)
- Sensus Healthcare, Inc.: 1 (https://510kreport.com/company/sensus-healthcare)
- Hologic, Inc.: 1 (https://510kreport.com/company/hologic)
- Invivo Corporation: 1 (https://510kreport.com/company/invivo)
- Vucomp, Inc.: 1 (https://510kreport.com/company/vucomp)

## Its most-cited devices
- K122951: Xoft Axxent Electronic Brachytherapy System Model 110 (2013), cited by 2
- K180125: PowerLook Density Assessment Software (2018), cited by 2
- K182373: PowerLook Tomo Detection V2 Software (2018), cited by 2
- K042697: Second Look Viewer (2004), cited by 2
- K121517: Versavue Enterprise Suite (2012), cited by 2
- K153570: Axxent Electronic Brachytherapy System Model 110 XP 1200 (2016), cited by 1

## Recent decisions
- K240417: ProFound Detection (V4.0) (Nov 8, 2024)
- K211506: PowerLook Density Assessment V4.0 (Jul 12, 2021)
- K203822: ProFound AI Software V3.0 (Mar 12, 2021)
- K191994: ProFound AI Software V2.1 (Oct 4, 2019)
- K182373: PowerLook Tomo Detection V2 Software (Dec 6, 2018)
- K180125: PowerLook Density Assessment Software (Apr 5, 2018)
- P160009: PowerLook® Tomo Detection Software (Mar 24, 2017)
- K153570: Axxent Electronic Brachytherapy System Model 110 XP 1200 (Feb 25, 2016)

Source page: https://510kreport.com/company/icad