GE LIGHTSPEED ACT FP16— 510(k) K091673
Substantially EquivalentGe Medical Systems, Inc.
FDA 510(k) clearance K091673 for GE LIGHTSPEED ACT FP16, Substantially Equivalent on 2009-06-24. Applicant: Ge Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Ge Medical Systems, Inc.
- Product code
- Code JAK
- Device class
- Class 2
- Regulation
- 21 CFR 892.1750
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Waukesha, WI, US
Recent devices under product code JAK
view allMore clearances from Ge Medical Systems, Inc.
view all- 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
- K033244 — DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT TABLE OPTION
Adverse events under product code JAK
product code JAK- Death
- 27
- Injury
- 571
- Malfunction
- 779
- Total
- 1,377
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 K091673
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 K091673.
Data sourced from openFDA. This site is unofficial and independent of the FDA.