The following data is part of a premarket notification filed by Examion Gmbh with the FDA for Examion X-aqs.
| Device ID | K170729 |
| 510k Number | K170729 |
| Device Name: | Examion X-AQS |
| Classification | System, Image Processing, Radiological |
| Applicant | Examion GmbH Erich-Herion Strassa 37 Fellbach, DE 70736 |
| Contact | Andreas Oppermann |
| Correspondent | Carl Alletto OTech Inc. 8317 Belew Drive Mckinney, TX 75071 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-09 |
| Decision Date | 2017-07-18 |
| Summary: | summary |