TBS iNsight

GUDID B214OSTBSI303

Bone absorptiometric x-ray system, dual-energy

Primary Device ID	B214OSTBSI303
NIH Device Record Key	25ca7804-18b0-4903-8e8e-c150487701bf
Commercial Distribution Status	In Commercial Distribution
Brand Name	TBS iNsight
Version Model Number	3.0.3.0
Company DUNS	289058302
Company Name	MED-IMAPS
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
HIBCC	B214OSTBSI30 [Previous]
HIBCC	B214OSTBSI303 [Primary]

KGI	Densitometer, Bone

Steralize Prior To Use	false
Device Is Sterile	false

B214OSTBSI303	TBS iNsight is a software provided for use as a complement to both DXA analysis and clinical exa
B214OSTBSI0	TBS iNsight is a software provided for use as a complement to both DXA analysis and clinical exa
B214OSTBSI3100	TBS iNsight is a software provided for use as a complement to both DXA analysis and clinical exa
B214OSTBSI3110	TBS iNsight is a software provided for use as a complement to both DXA analysis and clinical exa
B214OSTBSI3120	TBS iNsight is a software provided for use as a complement to both DXA analysis and clinical exa