Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Norland Corp. · Predicate Candidate Screening

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

141 daysmedian FDA review time

649 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days
K980569	FRACTURE RISK ASSESSMENT CAPABILITY FOR NORLAND X-RAY BONE D	Norland Corp.	1998-06-12	119
K980289	FRACTURE RISK ASSESSMENT FOR THE NORLAND SXA 3000 BONE DENSI	Norland Corp.	1998-06-12	137
K980125	REFERENCE POPULATION FOR NORLAND APOLLO X-RAY BONE DENSITOME	Norland Corp.	1998-05-20	126
K973459	NORLAND BODY COMPOSITION OPTION FOR NORLAND DEXA BONE DENSIT	Norland Corp.	1998-02-13	154
K973104	NORLAND MODEL PDEXA BONE DENSITOMETER	Norland Corp.	1998-01-29	163
K972882	APOLLO	Norland Corp.	1997-10-31	87
K931996	MODEL PDEXA BONE DENSITOMETER	Norland Corp.	1995-02-01	649
K926019	FORARM OPT/NORLAND XR SERIES X-RAY BONE DENSITOMET	Norland Corp.	1994-09-23	662
K922286	MODEL XCT-900 PQCT X-RAY BONE DENSITOMETER	Norland Corp.	1992-11-27	196
K913078	LATERAL SPINE OPT. XR-SERIES X-RAY BONE DENSITOMET	Norland Corp.	1991-09-24	75
K901804	NORLAND XR26 WHOLE BODY OPTION	Norland Corp.	1991-04-29	374
K902959	NORLAND XR26 LATERAL SPINE OPTION	Norland Corp.	1990-11-23	141
K881865	NORLAND MODEL XR-26 X-RAY BONE DENSITOMETER	Norland Corp.	1989-03-14	314
K841463	BONE DENSITOMETER	Norland Corp.	1984-07-17	99
K792444	NORLAND MODEL 278 BONE DENSITOMETER	Norland Corp.	1979-12-27	28

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