510(k) K043617
- Device
- IMAGECHECKER CT CAD SOFTWARE SYSTEM
- Applicant
- HOLOGIC, INC.
- 510(k) number
- K043617
- Product code
- OEB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-12-21
- Date received
- 2007-11-26
- Regulation
- 892.2050
- Classification name
- Lung Computed Tomography System, Computer-aided Detection
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ARTHUR FRIEDMAN
- Address
- 35 Crosby Dr. Bedford MA US 01730 01730
FDA Registration Numbers#
- 3001722928
- 9611343
- 3017936680
- 3005156333
- 3010601176
- 3005930550
- 3015169361
- 3005496266
- 3015763655
- 2134213
- 3004977335
Source Documents#
Other 510(k) Records For Product Code OEB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254075 | Synapse Lung Nodule AI | Fujifilm Corporation | 2026-05-27 |
| K251203 | AVIEW Lung Nodule CAD | Coreline Soft Co., Ltd. | 2025-12-03 |
| K240554 | InferRead Lung CT.AI | Infervision Medical Technology Co., Ltd. | 2025-05-16 |
| K242919 | V5med Lung AI | V5med, Inc. | 2025-03-27 |
| K231157 | syngo.CT Lung CAD (Version VD30) | Siemens Healthcare GmbH | 2023-07-19 |
| K221592 | AVIEW Lung Nodule CAD | Coreline Soft Co., Ltd. | 2023-02-24 |
| K221612 | ClearRead CT | Riverain Technologies, Inc. | 2022-12-05 |
| K203258 | syngo.CT Lung CAD | Siemens Healthcare GmbH | 2021-03-31 |
| K201501 | Veolity | MeVis Medical Solutions AG | 2021-02-23 |
| K192880 | InferRead Lung CT.AI | Beijing Infervision Technology Co., Ltd. | 2020-07-02 |
| K193216 | syngo.CT Lung CAD | Siemens Medi Cal Solutions, Inc. | 2020-03-09 |
| K161201 | ClearRead CT | Riverain Technologies, LLC | 2016-09-09 |
| K143196 | syngo.CT Lung CAD | Siemens AG Medical Solutions | 2015-05-12 |
| K063877 | SYNGO LUNG CAD | Siemens Medical Solutions USA, Inc. | 2006-10-18 |
| K042694 | ADVANCED LUNG ANALYSIS II | GE Medical Systems | 2004-11-18 |
Legacy Summary#
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FDA Review#
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