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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Achilles +; Achilles Express; Achilles Express Ultrasonometer; Achilles Insight; Achilles Insight Ultrasonometer
Classification Name: BONE SONOMETER
Product Code: MUA
Device Class: 2
Regulation Number: 892.1180
Medical Specialty: Radiology
Registered Establishment Name: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
Registered Establishment Number: 2124823
Owner/Operator: GENERAL ELECTRIC CO.
Owner/Operator Number: 9912004
Establishment Operations: Manufacturer; Remanufacturer
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