IMAGECHECKER CT CAD SOFTWARE SYSTEM
FDA 510(k) clearance K043617 · decided 2007-12-21
Clearance details
- K-number
- K043617
- Device name
- IMAGECHECKER CT CAD SOFTWARE SYSTEM
- Applicant
- Hologic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-11-26
- Decision date
- 2007-12-21
- Days to decision
- 25 days
- Clearance type
- Traditional
- Product code
- OEB
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Bedford, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Hologic
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Synapse Lung Nodule AI (K254075) | Fujifilm Corporation | 2026-05-27 |
| AVIEW Lung Nodule CAD (K251203) | Coreline Soft Co., Ltd. | 2025-12-03 |
| InferRead Lung CT.AI (K240554) | Infervision Medical Technology Co., Ltd. | 2025-05-16 |
| V5med Lung AI (K242919) | V5med, Inc. | 2025-03-27 |
| syngo.CT Lung CAD (Version VD30) (K231157) | Siemens Healthcare GmbH | 2023-07-19 |
| AVIEW Lung Nodule CAD (K221592) | Coreline Soft Co., Ltd. | 2023-02-24 |
| ClearRead CT (K221612) | Riverain Technologies, Inc. | 2022-12-05 |
| syngo.CT Lung CAD (K203258) | Siemens Healthcare GmbH | 2021-03-31 |
| Veolity (K201501) | MeVis Medical Solutions AG | 2021-02-23 |
| InferRead Lung CT.AI (K192880) | Beijing Infervision Technology Co., Ltd. | 2020-07-02 |
| syngo.CT Lung CAD (K193216) | Siemens Medi Cal Solutions, Inc. | 2020-03-09 |
| ClearRead CT (K161201) | Riverain Technologies, LLC | 2016-09-09 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| NovaSure Model 10 RF Controller (P010013/S094) | Hologic, Inc. | 2025-12-17 |
| Envision Mammography Platform (P080003/S011) | Hologic, Inc. | 2025-11-24 |
| Aptima HBV Quant Assay Kit, 100T; Aptima HBV Quant Calibrator Kit; Aptima HBV Quant Controls Kit; Aptima HBV Quant Targe (P170025/S023) | Hologic, Inc. | 2025-10-07 |
| ThinPrep Processor and ThinPrep Imaging System (P950039/S041) | Hologic, Inc. | 2025-08-27 |
| Rapid fFN Cassette Kit for the TLiIQ System, Rapid fFN Control for the TLiIQ System (P920048/S027) | Hologic, Inc. | 2024-12-06 |
| TLiIQ QCette (P920048/S026) | Hologic, Inc. | 2024-10-23 |
| Aptima CMV Quant Assay (P210029/S002) | Hologic, Inc. | 2024-10-23 |
| Aptima HBV Quant Assay (P170025/S022) | Hologic, Inc. | 2024-10-23 |