The following data is part of a premarket notification filed by Canon Medical Systems Corporation with the FDA for Low Dose Lung Screening Option.
| Device ID | K190505 |
| 510k Number | K190505 |
| Device Name: | Low Dose Lung Screening Option |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | Canon Medical Systems Corporation 1385 Shimoishigami Otawara, JP 3248550 |
| Contact | Paul Biggins |
| Correspondent | Paul Biggins Canon Medical Systems USA, Inc. 2441 Michelle Drive Tustin, CA 92780 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-01 |
| Decision Date | 2019-06-05 |