The following data is part of a premarket notification filed by Ge Medical Systems, Inc. with the FDA for Ge Lightspeed Act Fp16.
| Device ID | K091673 |
| 510k Number | K091673 |
| Device Name: | GE LIGHTSPEED ACT FP16 |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | GE MEDICAL SYSTEMS, INC. 3000 N. GRANDVIEW BLVD. Waukesha, WI 53188 |
| Contact | Allen Schuh |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-06-09 |
| Decision Date | 2009-06-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682141581 | K091673 | 000 |
| 00840682120272 | K091673 | 000 |