Phantom Ultrasound Software

GUDID 00850921007196

Specialized user interface software

INTERSON CORP

General-purpose ultrasound imaging system
Primary Device ID00850921007196
NIH Device Record Keyb8222929-cbe3-4dde-8e22-bd501c6369fa
Commercial Distribution StatusIn Commercial Distribution
Brand NamePhantom Ultrasound Software
Version Model Numberx.x
Company DUNS079884004
Company NameINTERSON CORP
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850921007196 [Primary]

FDA Product Code

IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-05-23
Device Publish Date2017-10-23

Devices Manufactured by INTERSON CORP

00850921007257 - VPS Rhythm DLX Ultrasound Probe2020-11-09 VPS Rhythm DLX Ultrasound Probe
00850921007271 - VPS Rhythm DLX Ultrasound Probe, Rebuilt2020-11-09 VPS Rhythm DLX Ultrasound Probe, Rebuilt
00850921007202 - I-Streme Echo Ultrasound Software2020-04-30
00850921007004 - Interson2018-05-23 USB ultrasound probe, general purpose/abdominal
00850921007011 - SeeMore2018-05-23 USB ultrasound probe, endocavity
00850921007028 - SeeMore2018-05-23 USB ultrasound probe, general purpose/abdominal
00850921007035 - SeeMore2018-05-23 USB ultrasound probe, general purpose/abdominal, with tablet computer
00850921007042 - SeeMore2018-05-23 USB ultrasound probe, small parts/vascular access

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