The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for Low Dose Ct Lung Cancer Screening Option For Qualified Ge Systems.
| Device ID | K151372 |
| 510k Number | K151372 |
| Device Name: | Low Dose CT Lung Cancer Screening Option For Qualified GE Systems |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | GE Medical Systems, LLC 3000 North Grandview Blvd Waukesha, WI 53188 |
| Contact | John Jaeckle |
| Correspondent | John Jaeckle GE Medical Systems, LLC 3000 North Grandview Blvd Waukesha, WI 53188 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-21 |
| Decision Date | 2015-08-14 |
| Summary: | summary |