PowerLook Density Assessment Software
by Icad, Inc.
510(k) K180125
PowerLook Density Assessment Software is a medical device (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Icad, Inc., cleared under FDA 510(k) K180125 on 5 Apr 2018, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK180125 | Date5 Apr 2018 | StatusActive |
Official records
- FDA 510(k) database K180125
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LLZ
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K180125
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| PowerLook AMP with Density Assessment GE OUS DSC012-03 | DSC012-03 | 00850008977190 | On the market | |
| PowerLook AMP with Density Assessment GE US DSC012-02 | DSC012-02 | 00850008977183 | On the market | |
| PowerLook Density Assessment V3.4 | D70141, D70142, D70160 / V3.4 | 00858012005922 | On the market |
Similar devices
Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).
- D2P by 3D SYSTEMS, INC.
- PRO VISION by Algotec Systems, Ltd.
- Nucleus.io by Nucleushealth, LLC
- 5D Viewer by SAMSUNG MEDISON CO., LTD.
- McKesson Cardiology by Change Healthcare Israel, Ltd.
- 21.3INCH (54CM)COLOR LCD MONITOR CCL256I2(CL21256) by Totoku Electric Co., Ltd.
- 21.3 (54 CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR, MODEL MS3112 (MDL2128A) by Totoku Electric Co., Ltd.
- hipEOS by Onefit Medical
- EndoNaut (Server) SW 1.x.x by Therenva Sas
- EzDent-i 3.5 by Ewoosoft Co., Ltd.