The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for Revolution Ct, Revolution Ct Es, Revolution Apex, Revolution Ct With Apex Edition.
| Device ID | K191777 |
| 510k Number | K191777 |
| Device Name: | Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT With Apex Edition |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | GE Medical Systems, LLC 3000 N. Grandview Blvd Waukesha, WI 53188 |
| Contact | Laura Turner |
| Correspondent | Laura Turner GE Medical Systems, LLC 3000 N. Grandview Blvd Waukesha, WI 53188 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-02 |
| Decision Date | 2019-07-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682146616 | K191777 | 000 |
| 00840682146319 | K191777 | 000 |