Ctxa Hip Extended Reference Data

510(k) Number

K030330 ↗

FDA product code

KGI

Device class

Class II

Regulation

21 CFR Part 892.1170

Advisory committee

Radiology

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code KGI (Densitometer, Bone).

• HOLOGIC QDR X-RAY BONE DENSITOMETER/MODELS SERIES 4500, 4000, 2000, 1000 AND HOLOGIC DELPHI X-RAY BONE DENSITOMETER by Hologic, Inc.
• HOLOGIC MODELS BLK-1, DPA/QDR-1 & QCT-1 by Hologic, Inc.
• APOLLO MULTI-RACIAL REFERENCE POPULATION by Norland Medical Systems, Inc.
• DPX SERIES BRAVO DUO BONE DENSITOMETER by Ge Lunar Corp.
• NA XCT 2000L by Stratec Medizintechnik GmbH
• EXPERT-XL ORTHOPEDIC HIP ACQUISITION AND ANALYSIS SOFTWARE by Lunar
• NORLAND MODEL 278 BONE DENSITOMETER by Norland Corp.
• NORLAND BODY COMPOSITION OPTION FOR NORLAND DEXA BONE DENSITOMETERS by Norland Corp.
• GADOLINIUM-153 BONE DENSITOMETER (GDC.10411/10412) by Amersham Corp.
• QCT-BONE MINERAL ANALYSIS SOFTWARE by Image Analysis Limited

• QCT PRO 3D Volumetric Spine Software K894854

  Class II

  FDA 510(k) ×3 Active Cleared 4 Dec 2001 GUDID on market

• CTXA Hip Bone Mineral Densitometer K002113

  Class II

  FDA 510(k) K002113 Active Cleared 4 Dec 2001 GUDID on market

• QCT Bone Mineral Density Analysis Software K894854

  Class II

  FDA 510(k) K894854 Active Cleared 19 Oct 1989 GUDID on market

• Model 4 CT Calibration Phantom

  Class II

  FDA 510(k) ×4 Active Cleared 4 Dec 2001 GUDID on market

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