Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Ge Medical Systems Ultrasound and Primary Care Dia · Predicate Candidate Screening

7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

17 daysmedian FDA review time
428 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K103730GE LUNAR VISCERAL FAT SOFTWAREGe Medical Systems Ultrasound and Primary Care Dia2011-05-061360
K072664GE LUNAR FEMUR STRENGTH SOFTWAREGe Medical Systems Ultrasound and Primary Care Dia2008-11-214280
K082185GE LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS 5205000, 52Ge Medical Systems Ultrasound and Primary Care Dia2008-08-15140
K073408GE LOGIQ BT08 DIAGNOSTIC ULTRASOUND SYSTEMGe Medical Systems Ultrasound and Primary Care Dia2007-12-19150
K072439GE LUNAR DPX & PRODIGY SERIES DEXA BONE DENSITOMETERS WITH MGe Medical Systems Ultrasound and Primary Care Dia2007-09-14150
K052581LUNAR IDXAGe Medical Systems Ultrasound and Primary Care Dia2005-10-20301
K041813GE LOGIQ 7 ULTRASOUND BT04Ge Medical Systems Ultrasound and Primary Care Dia2004-07-23170

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