The following data is part of a premarket notification filed by Ge Medical Systems,llc with the FDA for Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,revolution Ct; Revolution Ct Es; Revolution Ct With Apex Edition; Revolution Ct Es With Apex Edition.
| Device ID | K213715 |
| 510k Number | K213715 |
| Device Name: | Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,Revolution CT; Revolution CT ES; Revolution CT With Apex Edition; Revolution CT ES With Apex Edition |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | GE Medical Systems,LLC 3000 N Grandview Blvd. Waukesha, WI 53188 |
| Contact | Katelyn Rowley |
| Correspondent | Katelyn Rowley 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 | 2021-11-24 |
| Decision Date | 2021-12-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00195278469700 | K213715 | 000 |
| 00195278788665 | K213715 | 000 |