Product code KGI— Radiology

3D-SHAPER

Classification name: Densitometer, Bone
Device class: Class 2
Regulation: 21 CFR 892.1170
Advisory panel: Radiology
Total cleared: 148
First cleared: 1979-12-27
Most recent: 2026-09-11

Clearances under product code KGI — page 2

101–148 of 148

K934040 — THE OSTEOREPORTWoodson and Associates, LLC·1994-09-26
K926019 — FORARM OPT/NORLAND XR SERIES X-RAY BONE DENSITOMETNorland Corp.·1994-09-23
K926300 — DTX-100Hologic, Inc.·1993-07-23
K922286 — MODEL XCT-900 PQCT X-RAY BONE DENSITOMETERNorland Corp.·1992-11-27
K914404 — ORTHO SOFTWARE USED W/LUNAR DPX/DPX-L/DPS-@ DESITLunar·1992-02-27
K915535 — FOREARM SOFTWARE FOR LUNAR DPX SERIES BONE DESITOMLunar·1992-02-27
K913321 — HOLOGIC QDR-2000 X-RAY BONE DENSITOMETERHologic, Inc.·1991-11-01
K913078 — LATERAL SPINE OPT. XR-SERIES X-RAY BONE DENSITOMETNorland Corp.·1991-09-24
K905291 — LATERAL SPINE DETERMAINATIONS DPX/DPX-L/DPX-ALPHALunar·1991-08-09
K905753 — QDR-1000 AND QDR-1000/W X-RAY BONE DENSITOMETERHologic, Inc.·1991-06-10
K905691 — QDR-1000 AND WITH X-RAY BONE DENSITOMETERHologic, Inc.·1991-05-15
K901804 — NORLAND XR26 WHOLE BODY OPTIONNorland Corp.·1991-04-29
K904980 — DPX-L AND DPX-ALPHA, MODIFICATIONLunar·1990-12-05
K902959 — NORLAND XR26 LATERAL SPINE OPTIONNorland Corp.·1990-11-23
K894795 — HOLOGIC QDR-1000/W X-RAY BONE DENSITOMETERHologic, Inc.·1990-08-30
K901832 — GADOLINIUM-153 BONE DENSITOMETER SOURCES GDC.10415Amersham Corp.·1990-07-09
K901848 — GADOLINIUM-153 BONE DENSITOMETER SOURCESAmersham Corp.·1990-07-09
K901854 — GADOLINIUM-153 BONE DENSITOMETER (GDC.10411/10412)Amersham Corp.·1990-07-09
K901857 — GADOLINIUM-153 BONE DENSITOMETER (GDC.10413)Amersham Corp.·1990-07-09
K890121 — MODIFIED DPX BONE DENSITOMETERLunar·1990-04-10
K896677 — PC/QCT QUANTITATIVE SOFTWAREThe Institute For Radiological Image Sciences, Inc.·1990-01-23
K890999 — MODIFIED QDR-1000 X-RAY BONE DENSITOMETERHologic, Inc.·1989-12-21
K894854 — QCT BONE MINERAL DENSITY ANALYSIS SOFTWAREImage Enhancements·1989-10-19
K891582 — MODIFIED OSTEOANALYZER (# SPSHA110/220)Osteon, Inc.·1989-09-12
K884625 — DPX BONE DENSITOMETER FOR TOTAL BODY BONE DENSITYLunar·1989-06-23
K881383 — ND1100 BONE DENSITY SCANNERNuclear Data, Inc.·1989-05-22
K881865 — NORLAND MODEL XR-26 X-RAY BONE DENSITOMETERNorland Corp.·1989-03-14
K880404 — CSI/QCTColumbia Scientific, Inc.·1988-11-17
K883280 — HOLOGIC QDR-1000 X-RAY BONE DENSITOMETER/MODIFIEDHologic, Inc.·1988-09-29
K883360 — HOLOGIC MODEL WHF-1 ANTHROPOMORPHIC FEMUR PHANTOMHologic, Inc.·1988-09-27
K873296 — DPX BONE DENSITOMETERLunar Radiation Corp.·1988-06-06
K864299 — NOVO BMC-LAB 23, BONE DENSITOMETERScan Detectronic Laboratories, Inc.·1987-11-12
K871446 — HOLOGIC MODELS BLK-1, DPA/QDR-1 & QCT-1Hologic, Inc.·1987-10-20
K871553 — X-CALIBER MODEL 1000 BONE MINERAL ANALYZERHologic, Inc.·1987-10-08
K863618 — BONE MINERAL DENSITOMETRY OPTION B7918AAGeneral Electric Co.·1987-03-09
K861233 — DUAL PHOTON BONE DENSITOMETERMedical and Scientific Enterprises, Inc.·1987-03-03
K861515 — OSTEOPAK BMD (BONE MINERAL DENSITOMETER)Siemens Gammasonics, Inc.·1987-02-02
K852509 — QCT-BONE MINERAL PHANTOMImage Analysis, Inc.·1985-10-18
K852510 — COMPUTED TOMOGRAPHY COUCH PAD FOR MIN ANALYSISImage Analysis, Inc.·1985-10-18
K844835 — ND2100 SPINE SCANNERNuclear Data, Inc.·1985-04-18
K844766 — ND1100 BONE DENSITY SCANNERNuclear Data, Inc.·1985-04-16
K843922 — OSTEON BONE MINERAL ANALYZEROsteon, Inc.·1985-04-02
K841463 — BONE DENSITOMETERNorland Corp.·1984-07-17
K810140 — DUAL-PHOTON TOTAL BODY BONE MINERAL ANALunar Radiation Corp.·1981-02-12
K810159 — BONE MINERAL ANALYZER CONTROLLERLunar Radiation Corp.·1981-02-12
K802180 — WISCONSIN DUAL-PHOTON BONE ANALYZERLunar Radiation Corp.·1980-12-31
K802181 — WISCONSIN BONE MINERAL ANALYZERLunar Radiation Corp.·1980-12-31
K792444 — NORLAND MODEL 278 BONE DENSITOMETERNorland Corp.·1979-12-27

Data sourced from openFDA. This site is unofficial and independent of the FDA.