A-scan Plus Connect: Software Package

GUDID 00897826002185

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 ID00897826002185
NIH Device Record Key7830f99a-ee93-4bfb-a196-84e92da78e89
Commercial Distribution StatusIn Commercial Distribution
Brand NameA-scan Plus Connect: Software Package
Version Model Number7.00.02-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
GS100897826002185 [Primary]

FDA Product Code

ITXTransducer, Ultrasonic, Diagnostic

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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