GE ADVANCE NXI PET SYSTEM— 510(k) K003849
Substantially EquivalentGe Medical Systems, Inc.
FDA 510(k) clearance K003849 for GE ADVANCE NXI PET SYSTEM, Substantially Equivalent on 2000-12-22. Applicant: Ge Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Ge Medical Systems, Inc.
- Product code
- Code KPS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1200
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Milwaukee, WI, US
Recent devices under product code KPS
view allMore clearances from Ge Medical Systems, Inc.
view all- K091673 — GE LIGHTSPEED ACT FP16
- K082104 — GE LIGHTSPEED RT16 / LIGHTSPEED XTRA V2 CT SYSTEM (AKA GE LIGHTSPEED RT16 / LIGHTSPEED XTRA CT SYSTEM
- K042844 — GE SIGNA EXCITE 1.5T 6 CHANNEL PHASED ARRAY FLEX COIL, GE SIGNA EXCITE 3.0T 6 CHANNEL PHASED ARRAY FLEX COIL
- K042053 — INNOVA 4100, INNOVA 3100
- K040125 — SENOGRAPHIC STEREO
Data sourced from openFDA. This site is unofficial and independent of the FDA.