ADVANTAGE WINDOWS CT/PET FUSION— 510(k) K010336
Substantially EquivalentGe Medical Systems, Inc.
FDA 510(k) clearance K010336 for ADVANTAGE WINDOWS CT/PET FUSION, Substantially Equivalent on 2001-02-16. Applicant: Ge Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Ge Medical Systems, Inc.
- Product code
- Code LLZ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Milwaukee, WI, US
Recent devices under product code LLZ
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
Adverse events under product code LLZ
product code LLZ- Death
- 13
- Total
- 13
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K010336
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K010336.
Data sourced from openFDA. This site is unofficial and independent of the FDA.