The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for Ge Brightspeed Delight Ct Scanner System.
| Device ID | K082816 |
| 510k Number | K082816 |
| Device Name: | GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEM |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | GE MEDICAL SYSTEMS, LLC 3000 N GRANDVIEW BLVD. Waukesha, WI 53188 |
| Contact | Steven Kachelmeyer |
| Correspondent | James W Monroe INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-09-25 |
| Decision Date | 2008-10-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682138963 | K082816 | 000 |
| 00840682102551 | K082816 | 000 |