ND1100 Bone Density Scanner

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K881383 ↗

FDA Product Code

KGI

Device Class

Class II

Regulation

21 CFR Part 892.1170

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Accuspec Thyroid Uptake System

  Class I

  FDA 510(k) K891466 Active Cleared 6 Jun 1989

• ND2100 Spine Scanner

  Class II

  FDA 510(k) K844835 Active Cleared 18 Apr 1985

• ND1100 Bone Density Scanner

  Class II

  FDA 510(k) K844766 Active Cleared 16 Apr 1985

• ND3100 Video Imager

  Class I

  FDA 510(k) K843349 Active Cleared 17 Dec 1984

• ND62T Thyroid Uptake System

  Class I

  FDA 510(k) K841440 Active Cleared 5 Jun 1984

• ND1200 Ria Counter

  Class I

  FDA 510(k) K841352 Active Cleared 2 May 1984

• What is the ND1100 Bone Density Scanner used for?

  The ND1100 Bone Density Scanner is a Class II medical device designed to measure bone mineral density using radiographic techniques. It helps clinicians assess skeletal integrity, diagnose conditions like osteoporosis, and evaluate fracture risk. By quantifying bone mass, it supports evidence-based decisions for treatment planning and monitoring.

• Is the ND1100 Bone Density Scanner reusable or single-use?

  The ND1100 Bone Density Scanner is supplied as a reusable medical instrument. Since it is intended for clinical radiology use, it requires proper calibration and maintenance to ensure accurate and reliable bone density measurements over time. Standard infection control protocols must be followed during use.

• Does the ND1100 Bone Density Scanner have specific sterility requirements?

  The device does not specify sterility requirements beyond standard infection control protocols. As a reusable instrument, it must be cleaned and maintained according to manufacturer guidelines to prevent contamination and ensure safe clinical use. Always follow facility-specific protocols for disinfection and sterilization.

• What regulatory pathway does the ND1100 Bone Density Scanner follow?

  The ND1100 Bone Density Scanner is regulated under the FDA’s 510(k) clearance process, specifically with clearance number K881383. It falls under the Radiology advisory committee classification and is classified as a Class II device. The device was determined to be substantially equivalent to a predicate device, allowing it to enter the market under this regulatory route.

• Can the ND1100 Bone Density Scanner be used in an MRI environment?

  The ND1100 Bone Density Scanner is not explicitly classified as MRI-safe or MRI-unsafe. If used in an MRI environment, facility protocols should be consulted to ensure compatibility and safety. Radiographic devices like this one typically contain electronic components and materials that may interact with MRI fields, so caution is advised.