510(k) Report

Devices descending from K973104

36 later devices reach Norland Model Pdexa Bone Densitometer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K984178Pronosco X-Posure SystemTorsana Osteoporosis Diagnostics A/S19997—
+1K983028Fracture Risk Option for the QDR Bone Densitometer, Model#S QDR4500, QDR2000, QDR1500…Hologic, Inc.199825—
+1K980569Fracture Risk Assessment Capability for Norland X-Ray Bone DensitometersNorland Corp.19984—
+1K980289Fracture Risk Assessment for the Norland Sxa 3000 Bone DensitometerNorland Corp.19980—
+1K981124Accudexa Bone DensitometerSchick Technologies, Inc.19981—
+1K980125Reference Population for Norland Apollo X-Ray Bone DensitometerNorland Corp.19981—
+2K113725VirtuostO.N. Diagnostics20121—
+2K113616ACCUDXA2Lone Oak Medical Technologies, LLC20120—
+2K082402Osdx Hip BMD SystemImaging Therapeutics, Inc.20086—
+2K082317GE Lunar Frax 10-Year Fracture Risk Software OptionGeneral Electric Co.20087—
+2K0807111.10-Year Fracture Risk Questionnaire Option for QDR X-Ray Bone Densitometer, Model QDR…Hologic, Inc.200811
+2K023398Hologic QDR X-Ray Bone Densitometer, Models 1000, 2000, 4500, Delphi, DiscoveryHologic, Inc.2002191
+2K993176Multi-Racial Reference Population for Pdexa and DiscoveryNorland Medical Systems, Inc.20000—
+2K993337Apollo Multi-Racial Reference PopulationNorland Medical Systems, Inc.20000—
+2K992125XR 46 Dxa (Central) Bone Densitometer, Model XR 46Norland Medical Systems, Inc.199901
+2K983273XCT 2000 L PQCT Bone DensitometerMedical Systems, Inc.19980—
+3K220402VirtuOstO.N. Diagnostics20230—
+3K202514EchoS FamilyEcholight S.P.A20211—
+3K152299TBS iNsightMedimaps Group SA201642
+3K121716TBS InsightMedimaps Group SA20125—
+3K091325Ten-Year Fracture Risk Option and Siri Table Option for Norland Dxa Bone DensitometersCooper Surgical20090—
+3K072847Apex 2.0 Software for QDR X-Ray Bone DensitometersHologic, Inc.200809
+3K061561Hip Structural Analysis Software Option for the Hologic QDR X-Ray Bone DensitometersHologic, Inc.200613—
+3K042480Infant Whole Body Software Option for QDR DensitometersHologic, Inc.20041—
+3K041266Pediatric Reference DatabaseHologic, Inc.200401
+3K033224Hologic QDR Explorer X-Ray Bone Densitometer, Model ExplorerHologic, Inc.20031—
+4K243218TBS iNsight (V4)Medimaps Group SA20250—
+4K2208223D-Shaper3D-Shaper Medical S.L20221—
+4K212851EchoSK and EchoSGyn modules for EchoS Family devicesEcholight S.P.A20220—
+4K191112GEHC DXA Bone Densitometers with enCORE version 18GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201921
+4K133664Encore Version 16 Software for GE Lunar Dxa Bone DensitometersGe Medical Systems Ultrasound & Primary Care Diagn201401
+4K072664GE Lunar Femur Strength SoftwareGe Medical Systems Ultrasound and Primary Care Dia20087—
+5K252718Lunar AstraGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20260—
+5K2510223D-Shaper3D-Shaper Medical S.L20250—
+5K161682GE Lunar DXA Bone Densitometers with enCORE version 17GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201641
+6K180782AriaGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20180—