ClearanceBrief
Panels › Radiology › Product code KGI · Class 2

Densitometer, Bone

Regulation 892.1170

2510(k)s in 12 months (148 all time)
0recalls in 12 months (26 all time)
21recalls that name a 510(k)
Get daily alerts for KGISample briefCSV

Top companies in KGI

Company510(k)sRecalls
Hologic, Inc.2911
Lunar260
Norland Corp.150
GE Healthcare, LLC09
Image Analysis, Inc.70
Lunar Radiation Corp.50
Medimaps Group SA32
Amersham Corp.40
Ge Medical Systems Ultrasound and Primary Care Dia40
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC40
Decided510(k)Device and applicantCode
Jul 6, 2000K001756LUNAR REPORT GENERATOR II
Lunar Corp.
KGI
Jun 20, 2000K993176MULTI-RACIAL REFERENCE POPULATION FOR PDEXA AND DISCOVERY
Norland Medical Systems, Inc.
KGI
May 26, 2000K001429MODIFICATION TO ACCUDEXA BONE DENSITOMETER
Schick Technologies, Inc.
KGI
May 16, 2000K993337APOLLO MULTI-RACIAL REFERENCE POPULATION
Norland Medical Systems, Inc.
KGI
May 12, 2000K000162METRISCAN BONE DENSITY SYSTEM
Alara, Inc.
KGI
Apr 14, 2000K000826PRODIGY LATERAL VIEW SOFTWARE
Lunar Corp.
KGI
Nov 22, 1999K992125XR 46 DXA (CENTRAL) BONE DENSITOMETER, MODEL XR 46
Norland Medical Systems, Inc.
KGI
Oct 1, 1999K992775OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W
Hologic, Inc.
KGI
Sep 3, 1999K992677EAGLE OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W
Hologic, Inc.
KGI
Sep 3, 1999K992246QCT BONE MINERAL ANALYSIS SOFTWARE
Image Analysis, Inc.
KGI
May 19, 1999K984285OSTEOGRAM BONE DENSITOMETER
Compumed, Inc.
KGI
Feb 18, 1999K984178PRONOSCO X-POSURE SYSTEM
Torsana Osteoporosis Diagnostics A/S
KGI
Dec 8, 1998K983724ORCA-DX BONE DENSITOMETER
Lunar Corp.
KGI
Dec 8, 1998K983564PRODIGY TOTAL BODY SOFTWARE
Lunar Corp.
KGI
Nov 18, 1998K983271FRACTURE RISK ASSESSMENT OPTION FOR DPX SERIES BONE DENSITOMETERS
Lunar Corp.
KGI
Nov 18, 1998K983269FRACTURE RISK ASSESSMENT OPTION FOR EXPERT-XL BONE DENSITOMETER
Lunar Corp.
KGI
Nov 18, 1998K983262FRACTURE RISK ASSESSMENT OPTION FOR PIXI BONE DENSITOMETERS
Lunar Corp.
KGI
Nov 13, 1998K983028FRACTURE RISK OPTION FOR THE QDR BONE DENSITOMETER, MODEL#S QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W
Hologic, Inc.
KGI
Oct 29, 1998K983273XCT 2000 L PQCT BONE DENSITOMETER
Medical Systems, Inc.
KGI
Aug 18, 1998K982267DPX-RX BONE DENSITOMETER
Lunar Corp.
KGI
Jun 12, 1998K980569FRACTURE RISK ASSESSMENT CAPABILITY FOR NORLAND X-RAY BONE DENSITOMETERS
Norland Corp.
KGI
Jun 12, 1998K980289FRACTURE RISK ASSESSMENT FOR THE NORLAND SXA 3000 BONE DENSITOMETER
Norland Corp.
KGI
Jun 4, 1998K981124ACCUDEXA BONE DENSITOMETER
Schick Technologies, Inc.
KGI
May 20, 1998K980125REFERENCE POPULATION FOR NORLAND APOLLO X-RAY BONE DENSITOMETER
Norland Corp.
KGI
Feb 13, 1998K974437EXPERT-XL LATERAL SPINE BMD ACQUISITION AND ANALYSIS SOFTWARE
Lunar Corp.
KGI
Feb 13, 1998K973459NORLAND BODY COMPOSITION OPTION FOR NORLAND DEXA BONE DENSITOMETERS
Norland Corp.
KGI
Jan 29, 1998K973104NORLAND MODEL PDEXA BONE DENSITOMETER
Norland Corp.
KGI
Dec 2, 1997K971735ACCUDEXA BONE DENSITOMETER
Schick Technologies, Inc.
KGI
Nov 18, 1997K972517EXPERT-XL ORTHOPEDIC HIP ACQUISITION AND ANALYSIS SOFTWARE
Lunar Corp.
KGI
Oct 31, 1997K972882APOLLO
Norland Corp.
KGI
Aug 22, 1997K964562DTX-200 BONE DENSITOMETER
Osteometer Meditech A/S
KGI
Aug 8, 1997K972053PIXI YOUNG ADULT REFERENC POPULATION FOR OS CALCIS AND FOREARM
Lunar Corp.
KGI
Jul 14, 1997K963789DTX-100 BONE DENSITOMETER
Osteometer Meditech A/S
KGI
Jun 13, 1997K961787BODY COMPOSITION SOFTWARE OPTION FOR QDR X-RAY BONE DENSITOMETERS
Hologic, Inc.
KGI
Apr 16, 1997K970224PIXI BONE DENSITOMETER
Lunar Corp.
KGI
Apr 16, 1997K964307EXPANDED REFERENCE VALUES FOR DPX BON DENSITOMETERS
Lunar Corp.
KGI
Nov 22, 1996K963363HOLOGIC QDR SERIES X-RAY BOE DENSITOMETERS
Hologic, Inc.
KGI
Nov 7, 1996K964263EXPERT-KL AND HAND ACQUISITION AND ANALYSIS SOFTWARE
Lunar Corp.
KGI
Jul 25, 1996K961007EXPERT SPINE MORPHOTIETRY REFERENCE
Lunar Corp.
KGI
Jul 5, 1996K961011DTX-200 BONE DENSITOMETER
Shotwell & Carr, Inc.
KGI
Jul 3, 1996K961944LUNAR REPORT GENERATOR
Lunar Corp.
KGI
Oct 23, 1995K953032LUNAR DPX DENSITOMETER
Lunar Corp.
KGI
Aug 30, 1995K941362BONE MINERAL DENSITOMETER
Hologic, Inc.
KGI
Jun 5, 1995K952060QCT-BONE MINERAL ANALYSIS SOFTWARE OR OCT-BMD OPTION OR OCT-5000
Image Analysis, Inc.
KGI
May 24, 1995K950611EXPERT MORPHOMERTY SOFTWARD
Lunar Corp.
KGI
May 11, 1995K941127QCT-BONE MINERAL ANALYSIS SOFTWARE
Image Analysis, Inc.
KGI
May 3, 1995K941126QCT-BONE MINERAL ANALYSIS PHANTOM
Image Analysis, Inc.
KGI
Apr 25, 1995K945526LUNAR EXPERT
Lunar Corp.
KGI
Feb 1, 1995K931996MODEL PDEXA BONE DENSITOMETER
Norland Corp.
KGI
Jan 20, 1995K943505HOLOGIC QDR-3000 X-RAY BONE DENSITOMETER
Hologic, Inc.
KGI

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.