TBS iNsight

GUDID B214OSTBSI303

TBS iNsight is a software provided for use as a complement to both DXA analysis and clinical examination. It computes the antero-posterior spine DXA e

MED-IMAPS

Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy
Primary Device IDB214OSTBSI303
NIH Device Record Key25ca7804-18b0-4903-8e8e-c150487701bf
Commercial Distribution StatusIn Commercial Distribution
Brand NameTBS iNsight
Version Model Number3.0.3.0
Company DUNS289058302
Company NameMED-IMAPS
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1-608-669-9113
Emailsupport@medimapsgroup.com
Phone+1-608-669-9113
Emailsupport@medimapsgroup.com
Phone+1-608-669-9113
Emailsupport@medimapsgroup.com
Phone+1-608-669-9113
Emailsupport@medimapsgroup.com
Phone+1-608-669-9113
Emailsupport@medimapsgroup.com
Phone+1-608-669-9113
Emailsupport@medimapsgroup.com
Phone+1-608-669-9113
Emailsupport@medimapsgroup.com
Phone+1-608-669-9113
Emailsupport@medimapsgroup.com
Phone+1-608-669-9113
Emailsupport@medimapsgroup.com
Phone+1-608-669-9113
Emailsupport@medimapsgroup.com
Phone+1-608-669-9113
Emailsupport@medimapsgroup.com
Phone+1-608-669-9113
Emailsupport@medimapsgroup.com
Phone+1-608-669-9113
Emailsupport@medimapsgroup.com
Phone+1-608-669-9113
Emailsupport@medimapsgroup.com
Phone+1-608-669-9113
Emailsupport@medimapsgroup.com
Phone+1-608-669-9113
Emailsupport@medimapsgroup.com
Phone+1-608-669-9113
Emailsupport@medimapsgroup.com
Phone+1-608-669-9113
Emailsupport@medimapsgroup.com
Phone+1-608-669-9113
Emailsupport@medimapsgroup.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB214OSTBSI30 [Previous]
HIBCCB214OSTBSI303 [Primary]

FDA Product Code

KGIDensitometer, Bone

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-01
Device Publish Date2018-08-30

On-Brand Devices [TBS iNsight]

B214OSTBSI303TBS iNsight is a software provided for use as a complement to both DXA analysis and clinical exa
B214OSTBSI0TBS iNsight is a software provided for use as a complement to both DXA analysis and clinical exa
B214OSTBSI3100TBS iNsight is a software provided for use as a complement to both DXA analysis and clinical exa
B214OSTBSI3110TBS iNsight is a software provided for use as a complement to both DXA analysis and clinical exa
B214OSTBSI3120TBS iNsight is a software provided for use as a complement to both DXA analysis and clinical exa

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.