ImageChecker CT CAD Software System Model LN-1000
PMA P030012510(k) K043617
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK043617 | Date21 Dec 2007 | StatusActive |
| United States | FDA PMA PMA | NumberP030012 | Date8 Jul 2004 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k), FDA PMA Active
Specification
- Full name
- Imagechecker CT Cad Software System
- Generic name
- Lung computed tomography system, computer-aided diagnosis
- PMA number
- 510(k) Number
- FDA product code
- OEB
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The ImageChecker CT CAD Software System Model LN-1000 is a Lung Computed Tomography System, Computer-Aided Detection, designed to assist radiologists in identifying solid pulmonary nodules during the review of multidetector CT (MDCT) scans of the chest. It functions as an adjunct tool, providing automated alerts to regions of interest that may have been initially overlooked during manual interpretation.
This software system is intended for use in radiology settings and operates as a standalone application on compatible workstations. It is not classified as sterile or single-use; instead, it is a reusable digital solution requiring appropriate IT infrastructure and maintenance. The system holds FDA 510(k) clearance and FDA PMA approval, with regulatory oversight under product code OEB and device class II. Installation and use adhere to manufacturer guidelines for proper calibration and integration with existing imaging workflows.
Other devices from Hologic, Inc.
Questions
AI-generated answers, 18 Sep 2026
What is the primary purpose of the ImageChecker CT CAD Software System, and how does it assist radiologists in their workflow?
The ImageChecker CT CAD Software System (Model LN-1000) is designed as a computer-aided detection tool to help radiologists identify solid pulmonary nodules during the review of multidetector CT (MDCT) scans of the chest. It functions as an adjunct, providing automated alerts to regions of interest that may have been missed during manual interpretation, thereby supporting more thorough and efficient scan analysis.
Is the ImageChecker CT CAD Software System reusable, or is it intended for single-use? How does this affect its maintenance and setup?
The ImageChecker CT CAD Software System is a reusable digital solution, not classified as sterile or single-use. This means it requires proper IT infrastructure, regular maintenance, and adherence to manufacturer guidelines for calibration and integration with existing imaging workflows to ensure reliable performance.
Where is this software system approved for use, and what regulatory pathway was followed during its approval process?
The ImageChecker CT CAD Software System holds both FDA 510(k) clearance and FDA PMA approval, indicating it underwent regulatory review under product code OEB and is classified as a Class II device. The approval process included submission to the Radiology (RA) Advisory Committee, with the system deemed substantially equivalent to a predicate device.
What type of workstation compatibility does the ImageChecker CT CAD Software System require for installation and operation?
The ImageChecker CT CAD Software System operates as a standalone application on compatible workstations within radiology settings. While the exact hardware requirements are not specified, it relies on proper IT infrastructure to function effectively, including integration with existing imaging workflows and adherence to manufacturer guidelines for setup.
How does the ImageChecker CT CAD Software System differ from traditional manual CT scan interpretation methods?
Unlike manual CT scan interpretation, which relies solely on a radiologist’s visual assessment, the ImageChecker CT CAD Software System uses automated algorithms to flag potential solid pulmonary nodules that may have been overlooked during initial review. It serves as a secondary alert tool, aiding in more comprehensive detection without replacing the radiologist’s final interpretation.