Product Classification

• Device: densitometer, bone
• Regulation Description: Bone densitometer.
• Regulation Medical Specialty: Radiology
• Review Panel: Radiology
• Product Code: KGI
• Premarket Review: Office of Radiological Health (OHT8); Radiological Imaging Devices and Electronic Products (DHT8B)
• Submission Type: 510(k)
• Regulation Number: 892.1170
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Guidance Document

• Medical X-Ray Imaging Devices Conformance with IEC Standards: Guidance for Industry and Food and Drug Administration Staff

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• beanstock consulting
• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc