KGI
3D-SHAPER
- Advisory panel
- Radiology
- Total cleared
- 146
Adverse events under product code KGI
product code KGI- Other
- 1
- Total
- 1
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 →
Recent clearances under product code KGI
1–100 of 146- K251022 — 3D-SHAPER
- K242295 — BunkerHill BMD
- K243218 — TBS iNsight (V4)
- K220402 — VirtuOst
- K220822 — 3D-SHAPER
- K213760 — ABMD Software
- K191112 — GEHC DXA Bone Densitometers with enCORE version 18
- K180782 — Aria
- K161682 — GE Lunar DXA Bone Densitometers with enCORE version 17
- K152299 — TBS iNsight
- K140342 — QCT PRO ASYNCHRONOUS CALIBRATION MODULE, CLINIQCT
- K133664 — ENCORE VERSION 16 SOFTWARE FOR GE LUNAR DXA BONE DENSITOMETERS
- K130277 — SINGLE ENERGY (SE) FEMUR EXAMS
- K121716 — TBS INSIGHT
- K113725 — VIRTUOST
- K113286 — ENCORE 14 SOFTWARE RELEASE FOR THE GE LUNAR DXA BONE DENSITOMETERS
- K113616 — ACCUDXA2
- K113356 — HOLOGIC VISCERAL FAT SOFTWARE
- K103730 — GE LUNAR VISCERAL FAT SOFTWARE
- K103265 — NHANES WHOLE BODY DXA REFERENCE DATABASE
- K091325 — TEN-YEAR FRACTURE RISK OPTION AND SIRI TABLE OPTION FOR NORLAND DXA BONE DENSITOMETERS
- K072664 — GE LUNAR FEMUR STRENGTH SOFTWARE
- K082402 — OSDX HIP BMD SYSTEM
- K082317 — GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTION
- K080711 — 1.10-YEAR FRACTURE RISK QUESTIONNAIRE OPTION FOR QDR X-RAY BONE DENSITOMETER, MODEL QDR OPTION
- K072847 — APEX 2.0 SOFTWARE FOR QDR X-RAY BONE DENSITOMETERS
- K072439 — GE LUNAR DPX & PRODIGY SERIES DEXA BONE DENSITOMETERS WITH MOBILE KIT
- K071570 — GE LUNAR BODY COMPOSITION SOFTWARE
- K061561 — HIP STRUCTURAL ANALYSIS SOFTWARE OPTION FOR THE HOLOGIC QDR X-RAY BONE DENSITOMETERS
- K060111 — IVA (MXA II SOFTWARE OPTION)
- K052581 — LUNAR IDXA
- K042480 — INFANT WHOLE BODY SOFTWARE OPTION FOR QDR DENSITOMETERS
- K041266 — PEDIATRIC REFERENCE DATABASE
- K033550 — DXL CALSCAN
- K033224 — HOLOGIC QDR EXPLORER X-RAY BONE DENSITOMETER, MODEL EXPLORER
- K031991 — DXAVIEW SPINE AND HIP, MODEL QCT-3D PLUS
- K030962 — DPX SERIES BRAVO DUO BONE DENSITOMETER
- K030330 — CTXA HIP EXTENDED REFERENCE DATA
- K023554 — DUAL-ENERGY VERTEBRAL ASSESSMENT VIEW SOFTWARE
- K023398 — HOLOGIC QDR X-RAY BONE DENSITOMETER, MODELS 1000, 2000, 4500, DELPHI, DISCOVERY
- K021527 — SECTRA OSTEOPOROSIS PACKAGE
- K021331 — DEXACARE G4
- K002113 — CTXA HIP; CTXA; QCT PRO CTXA HIP
- K011917 — ADVANCED HIP ASSESSMENT SOFTWARE
- K003656 — X-POSURE SYSTEM VERSION 2 MAMMO
- K002500 — X-POSURE SYSTEM VERSION 2 RAD
- K002711 — HOLOGIC QDR X-RAY BONE DENSITOMETER/MODELS SERIES 4500, 4000, 2000, 1000 AND HOLOGIC DELPHI X-RAY BONE DENSITOMETER
- K001812 — PEDIATRIC REFERENCE DATA
- K001756 — LUNAR REPORT GENERATOR II
- K993176 — MULTI-RACIAL REFERENCE POPULATION FOR PDEXA AND DISCOVERY
- K001429 — MODIFICATION TO ACCUDEXA BONE DENSITOMETER
- K993337 — APOLLO MULTI-RACIAL REFERENCE POPULATION
- K000162 — METRISCAN BONE DENSITY SYSTEM
- K000826 — PRODIGY LATERAL VIEW SOFTWARE
- K992125 — XR 46 DXA (CENTRAL) BONE DENSITOMETER, MODEL XR 46
- K992775 — OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W
- K992246 — QCT BONE MINERAL ANALYSIS SOFTWARE
- K992677 — EAGLE OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W
- K984285 — OSTEOGRAM BONE DENSITOMETER
- K984178 — PRONOSCO X-POSURE SYSTEM
- K983564 — PRODIGY TOTAL BODY SOFTWARE
- K983724 — ORCA-DX BONE DENSITOMETER
- K983262 — FRACTURE RISK ASSESSMENT OPTION FOR PIXI BONE DENSITOMETERS
- K983269 — FRACTURE RISK ASSESSMENT OPTION FOR EXPERT-XL BONE DENSITOMETER
- K983271 — FRACTURE RISK ASSESSMENT OPTION FOR DPX SERIES BONE DENSITOMETERS
- K983028 — FRACTURE RISK OPTION FOR THE QDR BONE DENSITOMETER, MODEL#S QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W
- K983273 — XCT 2000 L PQCT BONE DENSITOMETER
- K982267 — DPX-RX BONE DENSITOMETER
- K980289 — FRACTURE RISK ASSESSMENT FOR THE NORLAND SXA 3000 BONE DENSITOMETER
- K980569 — FRACTURE RISK ASSESSMENT CAPABILITY FOR NORLAND X-RAY BONE DENSITOMETERS
- K981124 — ACCUDEXA BONE DENSITOMETER
- K980125 — REFERENCE POPULATION FOR NORLAND APOLLO X-RAY BONE DENSITOMETER
- K973459 — NORLAND BODY COMPOSITION OPTION FOR NORLAND DEXA BONE DENSITOMETERS
- K974437 — EXPERT-XL LATERAL SPINE BMD ACQUISITION AND ANALYSIS SOFTWARE
- K973104 — NORLAND MODEL PDEXA BONE DENSITOMETER
- K971735 — ACCUDEXA BONE DENSITOMETER
- K972517 — EXPERT-XL ORTHOPEDIC HIP ACQUISITION AND ANALYSIS SOFTWARE
- K972882 — APOLLO
- K964562 — DTX-200 BONE DENSITOMETER
- K972053 — PIXI YOUNG ADULT REFERENC POPULATION FOR OS CALCIS AND FOREARM
- K963789 — DTX-100 BONE DENSITOMETER
- K961787 — BODY COMPOSITION SOFTWARE OPTION FOR QDR X-RAY BONE DENSITOMETERS
- K964307 — EXPANDED REFERENCE VALUES FOR DPX BON DENSITOMETERS
- K970224 — PIXI BONE DENSITOMETER
- K963363 — HOLOGIC QDR SERIES X-RAY BOE DENSITOMETERS
- K964263 — EXPERT-KL AND HAND ACQUISITION AND ANALYSIS SOFTWARE
- K961007 — EXPERT SPINE MORPHOTIETRY REFERENCE
- K961011 — DTX-200 BONE DENSITOMETER
- K961944 — LUNAR REPORT GENERATOR
- K953032 — LUNAR DPX DENSITOMETER
- K941362 — BONE MINERAL DENSITOMETER
- K952060 — QCT-BONE MINERAL ANALYSIS SOFTWARE OR OCT-BMD OPTION OR OCT-5000
- K950611 — EXPERT MORPHOMERTY SOFTWARD
- K941127 — QCT-BONE MINERAL ANALYSIS SOFTWARE
- K941126 — QCT-BONE MINERAL ANALYSIS PHANTOM
- K945526 — LUNAR EXPERT
- K931996 — MODEL PDEXA BONE DENSITOMETER
- K943505 — HOLOGIC QDR-3000 X-RAY BONE DENSITOMETER
- K934040 — THE OSTEOREPORT
- K926019 — FORARM OPT/NORLAND XR SERIES X-RAY BONE DENSITOMET
Data sourced from openFDA. This site is unofficial and independent of the FDA.