Imagechecker CT Cad Software System
FDA 510(k) K043617 · Hologic, Inc.
510(k) numberK043617
Submission
- Device name
- Imagechecker CT Cad Software System
- Applicant
- Hologic, Inc.
Bedford, MA, US - Received
- November 26, 2007
- Decision date
- December 21, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OEB – Lung Computed Tomography System, Computer-Aided Detection
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.2050
- Specialty
- Radiology
To assist radiologists in the review of multi-slice computed tomography (msct) exams of the chest and highlight potential nodules that the radiologist should review. A computer aided diagnosis, lung computed tomography system is a class 3 device under product code NRR.
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| K240554 | InferRead Lung CT.AIOEB · Traditional | Infervision Medical Technology Co., Ltd. | 05/16/2025SE |
| K242919 | V5med Lung AIOEB · Traditional | V5med, Inc. | 03/27/2025SE |
| K231157 | syngo.CT Lung CAD (Version VD30)OEB · Traditional | Siemens Healthcare GmbH | 07/19/2023SE |
| K221592 | AVIEW Lung Nodule CADOEB · Traditional | Coreline Soft Co., Ltd. | 02/24/2023SE |
| K221612 | ClearRead CTOEB · Traditional | Riverain Technologies, Inc. | 12/05/2022SE |
| K203258 | syngo.CT Lung CADOEB · Traditional | Siemens Healthcare GmbH | 03/31/2021SE |
| K201501 | VeolityOEB · Traditional | MeVis Medical Solutions AG | 02/23/2021SE |
| K192880 | InferRead Lung CT.AIOEB · Traditional | Beijing Infervision Technology Co., Ltd. | 07/02/2020SE |
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Questions and answers
When was Imagechecker CT Cad Software System cleared by the FDA?
Imagechecker CT Cad Software System (K043617) received a 510(k) decision of Substantially Equivalent on December 21, 2007, 25 days after the submission was received.
What is the product code of K043617?
The FDA product code is OEB – Lung Computed Tomography System, Computer-Aided Detection, a Class II (moderate risk) device regulated under 21 CFR 892.2050.