FDA Product Code
FDA Product Code KGI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.1170
510(k) Clearances — 148 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K934040 | THE OSTEOREPORT | Woodson and Associates, LLC | 1994-09-26 | Traditional | PDF ↗ |
| K926019 | FORARM OPT/NORLAND XR SERIES X-RAY BONE DENSITOMET | Norland Corp. | 1994-09-23 | Traditional | PDF ↗ |
| K926300 | DTX-100 | Hologic, Inc. | 1993-07-23 | Traditional | PDF ↗ |
| K922286 | MODEL XCT-900 PQCT X-RAY BONE DENSITOMETER | Norland Corp. | 1992-11-27 | Traditional | PDF ↗ |
| K914404 | ORTHO SOFTWARE USED W/LUNAR DPX/DPX-L/DPS-@ DESIT | Lunar | 1992-02-27 | Traditional | PDF ↗ |
| K915535 | FOREARM SOFTWARE FOR LUNAR DPX SERIES BONE DESITOM | Lunar | 1992-02-27 | Traditional | PDF ↗ |
| K913321 | HOLOGIC QDR-2000 X-RAY BONE DENSITOMETER | Hologic, Inc. | 1991-11-01 | Traditional | PDF ↗ |
| K913078 | LATERAL SPINE OPT. XR-SERIES X-RAY BONE DENSITOMET | Norland Corp. | 1991-09-24 | Traditional | PDF ↗ |
| K905291 | LATERAL SPINE DETERMAINATIONS DPX/DPX-L/DPX-ALPHA | Lunar | 1991-08-09 | Traditional | PDF ↗ |
| K905753 | QDR-1000 AND QDR-1000/W X-RAY BONE DENSITOMETER | Hologic, Inc. | 1991-06-10 | Traditional | PDF ↗ |
| K905691 | QDR-1000 AND WITH X-RAY BONE DENSITOMETER | Hologic, Inc. | 1991-05-15 | Traditional | PDF ↗ |
| K901804 | NORLAND XR26 WHOLE BODY OPTION | Norland Corp. | 1991-04-29 | Traditional | PDF ↗ |
| K904980 | DPX-L AND DPX-ALPHA, MODIFICATION | Lunar | 1990-12-05 | Traditional | PDF ↗ |
| K902959 | NORLAND XR26 LATERAL SPINE OPTION | Norland Corp. | 1990-11-23 | Traditional | PDF ↗ |
| K894795 | HOLOGIC QDR-1000/W X-RAY BONE DENSITOMETER | Hologic, Inc. | 1990-08-30 | Traditional | PDF ↗ |
| K901857 | GADOLINIUM-153 BONE DENSITOMETER (GDC.10413) | Amersham Corp. | 1990-07-09 | Traditional | PDF ↗ |
| K901854 | GADOLINIUM-153 BONE DENSITOMETER (GDC.10411/10412) | Amersham Corp. | 1990-07-09 | Traditional | PDF ↗ |
| K901832 | GADOLINIUM-153 BONE DENSITOMETER SOURCES GDC.10415 | Amersham Corp. | 1990-07-09 | Traditional | PDF ↗ |
| K901848 | GADOLINIUM-153 BONE DENSITOMETER SOURCES | Amersham Corp. | 1990-07-09 | Traditional | PDF ↗ |
| K890121 | MODIFIED DPX BONE DENSITOMETER | Lunar | 1990-04-10 | Traditional | PDF ↗ |
| K896677 | PC/QCT QUANTITATIVE SOFTWARE | The Institute For Radiological Image Sciences, Inc. | 1990-01-23 | Traditional | PDF ↗ |
| K890999 | MODIFIED QDR-1000 X-RAY BONE DENSITOMETER | Hologic, Inc. | 1989-12-21 | Traditional | PDF ↗ |
| K894854 | QCT BONE MINERAL DENSITY ANALYSIS SOFTWARE | Image Enhancements | 1989-10-19 | Traditional | PDF ↗ |
| K891582 | MODIFIED OSTEOANALYZER (# SPSHA110/220) | Osteon, Inc. | 1989-09-12 | Traditional | PDF ↗ |
| K884625 | DPX BONE DENSITOMETER FOR TOTAL BODY BONE DENSITY | Lunar | 1989-06-23 | Traditional | PDF ↗ |
| K881383 | ND1100 BONE DENSITY SCANNER | Nuclear Data, Inc. | 1989-05-22 | Traditional | PDF ↗ |
| K881865 | NORLAND MODEL XR-26 X-RAY BONE DENSITOMETER | Norland Corp. | 1989-03-14 | Traditional | PDF ↗ |
| K880404 | CSI/QCT | Columbia Scientific, Inc. | 1988-11-17 | Traditional | PDF ↗ |
| K883280 | HOLOGIC QDR-1000 X-RAY BONE DENSITOMETER/MODIFIED | Hologic, Inc. | 1988-09-29 | Traditional | PDF ↗ |
| K883360 | HOLOGIC MODEL WHF-1 ANTHROPOMORPHIC FEMUR PHANTOM | Hologic, Inc. | 1988-09-27 | Traditional | PDF ↗ |
| K873296 | DPX BONE DENSITOMETER | Lunar Radiation Corp. | 1988-06-06 | Traditional | PDF ↗ |
| K864299 | NOVO BMC-LAB 23, BONE DENSITOMETER | Scan Detectronic Laboratories, Inc. | 1987-11-12 | Traditional | PDF ↗ |
| K871446 | HOLOGIC MODELS BLK-1, DPA/QDR-1 & QCT-1 | Hologic, Inc. | 1987-10-20 | Traditional | PDF ↗ |
| K871553 | X-CALIBER MODEL 1000 BONE MINERAL ANALYZER | Hologic, Inc. | 1987-10-08 | Traditional | PDF ↗ |
| K863618 | BONE MINERAL DENSITOMETRY OPTION B7918AA | General Electric Co. | 1987-03-09 | Traditional | PDF ↗ |
| K861233 | DUAL PHOTON BONE DENSITOMETER | Medical and Scientific Enterprises, Inc. | 1987-03-03 | Traditional | PDF ↗ |
| K861515 | OSTEOPAK BMD (BONE MINERAL DENSITOMETER) | Siemens Gammasonics, Inc. | 1987-02-02 | Traditional | PDF ↗ |
| K852510 | COMPUTED TOMOGRAPHY COUCH PAD FOR MIN ANALYSIS | Image Analysis, Inc. | 1985-10-18 | Traditional | PDF ↗ |
| K852509 | QCT-BONE MINERAL PHANTOM | Image Analysis, Inc. | 1985-10-18 | Traditional | PDF ↗ |
| K844835 | ND2100 SPINE SCANNER | Nuclear Data, Inc. | 1985-04-18 | Traditional | PDF ↗ |
| K844766 | ND1100 BONE DENSITY SCANNER | Nuclear Data, Inc. | 1985-04-16 | Traditional | PDF ↗ |
| K843922 | OSTEON BONE MINERAL ANALYZER | Osteon, Inc. | 1985-04-02 | Traditional | PDF ↗ |
| K841463 | BONE DENSITOMETER | Norland Corp. | 1984-07-17 | Traditional | PDF ↗ |
| K810140 | DUAL-PHOTON TOTAL BODY BONE MINERAL ANA | Lunar Radiation Corp. | 1981-02-12 | Traditional | PDF ↗ |
| K810159 | BONE MINERAL ANALYZER CONTROLLER | Lunar Radiation Corp. | 1981-02-12 | Traditional | PDF ↗ |
| K802180 | WISCONSIN DUAL-PHOTON BONE ANALYZER | Lunar Radiation Corp. | 1980-12-31 | Traditional | PDF ↗ |
| K802181 | WISCONSIN BONE MINERAL ANALYZER | Lunar Radiation Corp. | 1980-12-31 | Traditional | PDF ↗ |
| K792444 | NORLAND MODEL 278 BONE DENSITOMETER | Norland Corp. | 1979-12-27 | Traditional | PDF ↗ |
Product code KGI · Class II · Radiology. Data: openFDA.