510(k) Report

Devices descending from K980569

4 later devices reach Fracture Risk Assessment Capability for Norland X-Ray Bone Densitometers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K993176Multi-Racial Reference Population for Pdexa and DiscoveryNorland Medical Systems, Inc.20000—
+1K993337Apollo Multi-Racial Reference PopulationNorland Medical Systems, Inc.20000—
+1K992125XR 46 Dxa (Central) Bone Densitometer, Model XR 46Norland Medical Systems, Inc.199901
+1K983273XCT 2000 L PQCT Bone DensitometerMedical Systems, Inc.19980—