Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
KGI — Predicate Candidate Screening
147 FDA 510(k) clearances under this product code; the 50 most recent screened below.
120 daysmedian FDA review time
374 days90th percentile
147clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252718 | Lunar Astra | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2026-04-20 | 235 | 0 |
| K251022 | 3D-SHAPER | 3D-Shaper Medical S.L | 2025-09-05 | 156 | 0 |
| K242295 | BunkerHill BMD | BunkerHill Health | 2025-04-08 | 249 | 0 |
| K243218 | TBS iNsight (V4) | Medimaps Group SA | 2025-01-17 | 105 | 0 |
| K220402 | VirtuOst | O.N. Diagnostics | 2023-05-19 | 462 | 0 |
| K220822 | 3D-SHAPER | 3D-Shaper Medical S.L | 2022-12-09 | 263 | 0 |
| K213760 | ABMD Software | HeartLung Corporation | 2022-07-29 | 240 | 0 |
| K191112 | GEHC DXA Bone Densitometers with enCORE version 18 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2019-09-19 | 146 | 1 |
| K180782 | Aria | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2018-04-20 | 25 | 0 |
| K161682 | GE Lunar DXA Bone Densitometers with enCORE version 17 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2016-12-02 | 168 | 1 |
| K152299 | TBS iNsight | Medimaps Group SA | 2016-04-29 | 260 | 2 |
| K140342 | QCT PRO ASYNCHRONOUS CALIBRATION MODULE, CLINIQCT | Mindways Software, Inc. | 2014-08-29 | 199 | 0 |
| K133664 | ENCORE VERSION 16 SOFTWARE FOR GE LUNAR DXA BONE DENSITOMETE | Ge Medical Systems Ultrasound & Primary Care Diagn | 2014-05-15 | 167 | 1 |
| K130277 | SINGLE ENERGY (SE) FEMUR EXAMS | Hologic, Inc. | 2013-05-31 | 116 | 0 |
| K121716 | TBS INSIGHT | Medimaps Group SA | 2012-10-05 | 116 | 0 |
| K113725 | VIRTUOST | O.N. Diagnostics | 2012-09-13 | 269 | 0 |
| K113616 | ACCUDXA2 | Lone Oak Medical Technologies, LLC | 2012-04-27 | 142 | 0 |
| K113286 | ENCORE 14 SOFTWARE RELEASE FOR THE GE LUNAR DXA BONE DENSITO | Ge Medical Systems Lunar | 2012-04-27 | 172 | 0 |
| K113356 | HOLOGIC VISCERAL FAT SOFTWARE | Hologic, Inc. | 2012-03-06 | 113 | 0 |
| K103730 | GE LUNAR VISCERAL FAT SOFTWARE | Ge Medical Systems Ultrasound and Primary Care Dia | 2011-05-06 | 136 | 0 |
| K103265 | NHANES WHOLE BODY DXA REFERENCE DATABASE | Hologic, Inc. | 2011-03-16 | 132 | 0 |
| K091325 | TEN-YEAR FRACTURE RISK OPTION AND SIRI TABLE OPTION FOR NORL | Cooper Surgical | 2009-06-29 | 55 | 0 |
| K072664 | GE LUNAR FEMUR STRENGTH SOFTWARE | Ge Medical Systems Ultrasound and Primary Care Dia | 2008-11-21 | 428 | 0 |
| K082402 | OSDX HIP BMD SYSTEM | Imaging Therapeutics, Inc. | 2008-10-16 | 57 | 0 |
| K082317 | GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTION | General Electric Co. | 2008-09-26 | 44 | 0 |
| K080711 | 1.10-YEAR FRACTURE RISK QUESTIONNAIRE OPTION FOR QDR X-RAY B | Hologic, Inc. | 2008-09-02 | 173 | 1 |
| K072847 | APEX 2.0 SOFTWARE FOR QDR X-RAY BONE DENSITOMETERS | Hologic, Inc. | 2008-03-28 | 176 | 9 |
| K072439 | GE LUNAR DPX & PRODIGY SERIES DEXA BONE DENSITOMETERS WITH M | Ge Medical Systems Ultrasound and Primary Care Dia | 2007-09-14 | 15 | 0 |
| K071570 | GE LUNAR BODY COMPOSITION SOFTWARE | Ge Medical Systems Lunar | 2007-06-27 | 19 | 0 |
| K061561 | HIP STRUCTURAL ANALYSIS SOFTWARE OPTION FOR THE HOLOGIC QDR | Hologic, Inc. | 2006-07-28 | 53 | 0 |
| K060111 | IVA (MXA II SOFTWARE OPTION) | Hologic, Inc. | 2006-04-24 | 97 | 0 |
| K052581 | LUNAR IDXA | Ge Medical Systems Ultrasound and Primary Care Dia | 2005-10-20 | 30 | 1 |
| K042480 | INFANT WHOLE BODY SOFTWARE OPTION FOR QDR DENSITOMETERS | Hologic, Inc. | 2004-10-29 | 46 | 0 |
| K041266 | PEDIATRIC REFERENCE DATABASE | Hologic, Inc. | 2004-08-11 | 91 | 1 |
| K033550 | DXL CALSCAN | Demetech AB | 2004-05-05 | 175 | 0 |
| K033224 | HOLOGIC QDR EXPLORER X-RAY BONE DENSITOMETER, MODEL EXPLORER | Hologic, Inc. | 2003-11-05 | 30 | 0 |
| K031991 | DXAVIEW SPINE AND HIP, MODEL QCT-3D PLUS | Image Analysis, Inc. | 2003-07-30 | 33 | 0 |
| K030962 | DPX SERIES BRAVO DUO BONE DENSITOMETER | Ge Lunar Corp. | 2003-07-25 | 120 | 0 |
| K030330 | CTXA HIP EXTENDED REFERENCE DATA | Mindways Software, Inc. | 2003-06-20 | 140 | 0 |
| K023554 | DUAL-ENERGY VERTEBRAL ASSESSMENT VIEW SOFTWARE | Ge Lunar Corp. | 2002-12-20 | 58 | 0 |
| K023398 | HOLOGIC QDR X-RAY BONE DENSITOMETER, MODELS 1000, 2000, 4500 | Hologic, Inc. | 2002-11-08 | 30 | 1 |
| K021527 | SECTRA OSTEOPOROSIS PACKAGE | Sectra-Imtec AB | 2002-06-07 | 28 | 0 |
| K021331 | DEXACARE G4 | Osteometer Meditech, Inc. | 2002-05-21 | 25 | 0 |
| K002113 | CTXA HIP; CTXA; QCT PRO CTXA HIP | Mindways Software, Inc. | 2001-12-04 | 545 | 0 |
| K011917 | ADVANCED HIP ASSESSMENT SOFTWARE | Ge Lunar Corp. | 2001-08-03 | 44 | 0 |
| K003656 | X-POSURE SYSTEM VERSION 2 MAMMO | Pronosco A/S | 2000-12-15 | 18 | 0 |
| K002500 | X-POSURE SYSTEM VERSION 2 RAD | Pronosco A/S | 2000-10-23 | 70 | 0 |
| K002711 | HOLOGIC QDR X-RAY BONE DENSITOMETER/MODELS SERIES 4500, 4000 | Hologic, Inc. | 2000-09-28 | 28 | 0 |
| K001812 | PEDIATRIC REFERENCE DATA | Lunar Corp. | 2000-07-10 | 25 | 0 |
| K001756 | LUNAR REPORT GENERATOR II | Lunar Corp. | 2000-07-06 | 27 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda