The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Invenia Abus Viewer.
| Device ID | K180641 |
| 510k Number | K180641 |
| Device Name: | Invenia ABUS Viewer |
| Classification | System, Image Processing, Radiological |
| Applicant | GE Healthcare 9900 Innovation Drive Wauwatosa, WI 53226 |
| Contact | Bryan Behn |
| Correspondent | Bryan Behn GE Healthcare 9900 Innovation Drive Wauwatosa, WI 53226 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-12 |
| Decision Date | 2018-05-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682141109 | K180641 | 000 |