The following data is part of a premarket notification filed by Hitachi Healthcare Americas with the FDA for Low Dose Ct Lung Cancer Screening Option.
| Device ID | K180901 |
| 510k Number | K180901 |
| Device Name: | Low Dose CT Lung Cancer Screening Option |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | Hitachi Healthcare Americas 1959 Summit Commerce Park Twinsburg, OH 44087 |
| Contact | Doug Thistlethwaite |
| Correspondent | Doug Thistlethwaite Hitachi Healthcare Americas 1959 Summit Commerce Park Twinsburg, OH 44087 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-06 |
| Decision Date | 2018-05-16 |
| Summary: | summary |