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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Rho
Classification Name: RADIOLOGY SOFTWARE FOR OPPORTUNISTIC EVALUATION OF LOW BONE MINERAL DENSITY
Product Code: SAO
Device Class: 2
Regulation Number: 892.1171
Medical Specialty: Radiology
Registered Establishment Name: 16 BIT INC
Registered Establishment Number: 3033583855
Premarket Submission Number: DEN230023
Owner/Operator: 16 Bit Inc
Owner/Operator Number: 10091425
Establishment Operations: Manufacturer
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