SYNGO LUNG CAD
FDA premarket approval P050022 · decided 2006-10-18
Approval details
- PMA number
- P050022
- Trade name
- SYNGO LUNG CAD
- Generic name
- Lung computed tomography system, computer-aided diagnosis
- Applicant
- Siemens Medical Solutions USA, Inc.
- Date received
- 2005-06-30
- Decision date
- 2006-10-18
- Days to decision
- 475 days
- Decision code
- APCV
- Product code
- NRR
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Malvern, PA
- Statement
- APPROVAL FOR THE SYNGO LUNG CAD SOFTWARE DEVICE. THE DEVICE IS INDICATED TO ASSIST RADIOLOGISTS IN THE DETECTION OF SOLID PULMONARY NODULES DURING REVIEW OF MULTI-DETECTOR COMPUTED TOMOGRAPHY (MDCT) EXAMINATIONS OF THE CHEST. THE SOFTWARE IS AN ADJUNCTIVE TOOL TO ALERT THE RADIOLOGIST TO REGIONS OF INTEREST (ROI) THAT MAY HAVE BEEN INITIALLY OVERLOOKED. THE LUNG CAD SOFTWARE DEVICE IS INTENDED TO BE USED AS A SECOND READER AFTER THE RADIOLOGIST HAS COMPLETED HIS/HER INITIAL READ.
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510(k) clearances by this applicant
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|---|---|---|
| syngo.CT Coronary Cockpit (K253786) | Siemens Medical Solutions USA, Inc. | 2026-06-25 |
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| syngo Application Software (K254184) | Siemens Medical Solutions USA, Inc. | 2026-04-29 |
| ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno (K254173) | Siemens Medical Solutions USA, Inc. | 2026-04-24 |
| ARTIS genio floor; ARTIS icono.explore floor (K253752) | Siemens Medical Solutions USA, Inc. | 2026-04-23 |
| SOMATOM X.cite; SOMATOM X.ceed (K253574) | Siemens Medical Solutions USA, Inc. | 2026-03-20 |