Icad, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Icad, Inc.” (first 2004, latest 2024), plus 4 PMA decisions, across 7 product codes in 1 review panel. Median 510(k) review time under this name: 76 days. Since 2017 the median was 76 days, against 131 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 59 |
| 2013 | 2 | 112 |
| 2014 | 1 | 107 |
| 2015 | 0 | — |
| 2016 | 1 | 73 |
| 2017 | 0 | — |
| 2018 | 2 | 88 |
| 2019 | 1 | 70 |
| 2020 | 0 | — |
| 2021 | 2 | 66 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 269 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Icad, Inc. took a median 76 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 131 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 4 | 4 |
| MYN | Analyzer, Medical Image | 4 | 0 |
| QDQ | Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer | 4 | 4 |
| JAD | System, Therapeutic, X-Ray | 3 | 3 |
| JAK | System, X-Ray, Tomography, Computed | 1 | 1 |
| JAQ | System, Applicator, Radionuclide, Remote-Controlled | 1 | 1 |
| QIH | Automated Radiological Image Processing Software | 1 | 1 |
Review panels
- Radiology (18)
Most recent Icad, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K240417 | ProFound Detection (V4.0) | QDQ | 2024-11-08 | 269 |
| K211506 | PowerLook Density Assessment V4.0 | QIH | 2021-07-12 | 59 |
| K203822 | ProFound AI Software V3.0 | QDQ | 2021-03-12 | 73 |
| K191994 | ProFound AI Software V2.1 | QDQ | 2019-10-04 | 70 |
| K182373 | PowerLook Tomo Detection V2 Software | QDQ | 2018-12-06 | 97 |
| K180125 | PowerLook Density Assessment Software | LLZ | 2018-04-05 | 79 |
| K153570 | Axxent Electronic Brachytherapy System Model 110 XP 1200 | JAD | 2016-02-25 | 73 |
| K141343 | AXXENT CERVICAL APPLICATOR | JAD | 2014-09-05 | 107 |
| K123442 | XOFT AXXENT CERVICAL APPLICATORS | JAQ | 2013-02-27 | 111 |
| K122951 | XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM MODEL 110 | JAD | 2013-01-17 | 114 |
4 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P160009 | PMA | PowerLook® Tomo Detection Software | 2017-03-24 |
| P100005 | PMA | M-VU ALGORITHM ENGINE | 2012-01-23 |
| P010034 | PMA | SECOND LOOK (TM) | 2002-01-31 |
| P010038 | PMA | SECOND LOOK | 2002-01-15 |
Recalls
3 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2015-01-21.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Icad, Inc.?
FDA lists 14 510(k) clearances under the applicant name “Icad, Inc.” (first 2004, latest 2024), plus 4 PMA decisions, across 7 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Icad, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Icad, Inc. is 76 days. Since 2017: 76 days, versus 131 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Icad, Inc.?
The most frequent FDA product codes under this applicant name are LLZ (System, Image Processing, Radiological, 4); MYN (Analyzer, Medical Image, 4); QDQ (Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer, 4).
Next steps
- See all 14 Icad, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Icad, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.