B-scan Plus: Software Package

GUDID 00897826002178

ACCUTOME, INC.

Ophthalmic ultrasound imaging system Ophthalmic ultrasound imaging system Ophthalmic ultrasound imaging system Ophthalmic ultrasound imaging system Ophthalmic ultrasound imaging system Ophthalmic ultrasound imaging system Ophthalmic ultrasound imaging system Ophthalmic ultrasound imaging system Ophthalmic ultrasound imaging system Ophthalmic ultrasound imaging system Ophthalmic ultrasound imaging system Ophthalmic ultrasound imaging system Ophthalmic ultrasound imaging system Ophthalmic ultrasound imaging system Ophthalmic ultrasound imaging system Ophthalmic ultrasound imaging system
Primary Device ID00897826002178
NIH Device Record Key13522914-15a5-4447-b6bc-1b235632d154
Commercial Distribution StatusIn Commercial Distribution
Brand NameB-scan Plus: Software Package
Version Model Number4.07.02-U
Company DUNS048792816
Company NameACCUTOME, INC.
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 Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100897826002178 [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 Number4
Public Version Date2021-11-29
Device Publish Date2016-09-21

Devices Manufactured by ACCUTOME, INC.

00897826002000 - Accupen2021-11-29
00897826002017 - Pachpen2021-11-29
00897826002024 - A-scan Plus Connect2021-11-29
00897826002031 - B-scan Plus2021-11-29
00897826002055 - Accupach VI2021-11-29
00897826002062 - B-scan Pro2021-11-29
00897826002079 - 4Sight2021-11-29
00897826002086 - AccuTip Cover2021-11-29 Individually wrapped

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