KGI · Class II · 21 CFR 892.1170

FDA Product Code KGI: Densitometer, Bone

Leading manufacturers include Hologic, Inc., Lunar Corp. and Norland Corp..

148
Total
148
Cleared
156d
Avg days
1979
Since
148 devices
121–144 of 148
Cleared Jan 23, 1990
PC/QCT QUANTITATIVE SOFTWARE
K896677
The Institute For Radiological Image Sciences, Inc.
Radiology · 57d
Cleared Dec 21, 1989
MODIFIED QDR-1000 X-RAY BONE DENSITOMETER
K890999
Hologic, Inc.
Radiology · 297d
Cleared Oct 19, 1989
QCT BONE MINERAL DENSITY ANALYSIS SOFTWARE
K894854
Image Enhancements
Radiology · 80d
Cleared Sep 12, 1989
MODIFIED OSTEOANALYZER (# SPSHA110/220)
K891582
Osteon, Inc.
Radiology · 176d
Cleared Jun 23, 1989
DPX BONE DENSITOMETER FOR TOTAL BODY BONE DENSITY
K884625
Lunar
Radiology · 231d
Cleared May 22, 1989
ND1100 BONE DENSITY SCANNER
K881383
Nuclear Data, Inc.
Radiology · 416d
Cleared Mar 14, 1989
NORLAND MODEL XR-26 X-RAY BONE DENSITOMETER
K881865
Norland Corp.
Radiology · 314d
Cleared Nov 17, 1988
CSI/QCT
K880404
Columbia Scientific, Inc.
Radiology · 293d
Cleared Sep 29, 1988
HOLOGIC QDR-1000 X-RAY BONE DENSITOMETER/MODIFIED
K883280
Hologic, Inc.
Radiology · 57d
Cleared Sep 27, 1988
HOLOGIC MODEL WHF-1 ANTHROPOMORPHIC FEMUR PHANTOM
K883360
Hologic, Inc.
Radiology · 49d
Cleared Jun 06, 1988
DPX BONE DENSITOMETER
K873296
Lunar Radiation Corp.
Radiology · 294d
Cleared Nov 12, 1987
NOVO BMC-LAB 23, BONE DENSITOMETER
K864299
Scan Detectronic Laboratories, Inc.
Radiology · 377d
Cleared Oct 20, 1987
HOLOGIC MODELS BLK-1, DPA/QDR-1 & QCT-1
K871446
Hologic, Inc.
Radiology · 190d
Cleared Oct 08, 1987
X-CALIBER MODEL 1000 BONE MINERAL ANALYZER
K871553
Hologic, Inc.
Radiology · 169d
Cleared Mar 09, 1987
BONE MINERAL DENSITOMETRY OPTION B7918AA
K863618
General Electric Co.
Radiology · 174d
Cleared Mar 03, 1987
DUAL PHOTON BONE DENSITOMETER
K861233
Medical and Scientific Enterprises, Inc.
Radiology · 336d
Cleared Feb 02, 1987
OSTEOPAK BMD (BONE MINERAL DENSITOMETER)
K861515
Siemens Gammasonics, Inc.
Radiology · 285d
Cleared Oct 18, 1985
QCT-BONE MINERAL PHANTOM
K852509
Image Analysis, Inc.
Radiology · 128d
Cleared Oct 18, 1985
COMPUTED TOMOGRAPHY COUCH PAD FOR MIN ANALYSIS
K852510
Image Analysis, Inc.
Radiology · 128d
Cleared Apr 18, 1985
ND2100 SPINE SCANNER
K844835
Nuclear Data, Inc.
Radiology · 127d
Cleared Apr 16, 1985
ND1100 BONE DENSITY SCANNER
K844766
Nuclear Data, Inc.
Radiology · 130d
Cleared Apr 02, 1985
OSTEON BONE MINERAL ANALYZER
K843922
Osteon, Inc.
Radiology · 179d
Cleared Jul 17, 1984
BONE DENSITOMETER
K841463
Norland Corp.
Radiology · 99d
Cleared Feb 12, 1981
DUAL-PHOTON TOTAL BODY BONE MINERAL ANA
K810140
Lunar Radiation Corp.
Radiology · 22d