The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Universal Viewer.
| Device ID | K211312 |
| 510k Number | K211312 |
| Device Name: | Universal Viewer |
| Classification | System, Image Processing, Radiological |
| Applicant | GE Healthcare 500 W. Monroe Street Chicago, IL 60661 -3671 |
| Contact | John Braam |
| Correspondent | John Braam GE Healthcare 500 W. Monroe Street Chicago, IL 60661 -3671 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-30 |
| Decision Date | 2021-05-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00195278379610 | K211312 | 000 |