FDA.reportPublic FDA data

B-scan Plus: Software Package

Primary DI
00897826002178
Brand
B-scan Plus: Software Package
Company
ACCUTOME, INC.
Model
4.07.02-U
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00897826002178PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00897826002178008978260021788978260021780897826002178

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic ultrasound imaging systemAn assembly of mains electricity (AC-powered) devices designed for ophthalmic imaging procedures. It includes software that supports a variety of static and real-time eye and orbital imaging applications including physical measurement and oncology related treatment. It will generate ultrasound pulses, direct them to a target area, detect the resulting ultrasound echoes, and process the resulting information producing and displaying static or dynamic two- or three-dimensional (3-D) images. This GMDN code includes ultrasound imaging systems with, e.g., A-mode, B-mode, Doppler, colour Doppler (CD), M-mode, and duplex (combination imaging, Doppler and/or colour flow) scanning capabilities.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
048792816
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00897826002086AccuTip CoverAX9950AX99502016-09-13
00897826002093AccuTip Cover AX11932AX119322016-09-13
00897826002109AccuTip Cover AX11526AX115262016-09-13
00897826002116AccuTip Cover AX11286AX112862016-09-13
00897826002000Accupen24-300024-30002016-09-13
00897826002017Pachpen24-510024-51002016-09-13
00897826002024A-scan Plus Connect24-440024-44002016-09-13
00897826002031B-scan Plus24-610024-61002016-09-13
00897826002055Accupach VI24-620024-62002016-09-13
00897826002062B-scan Pro24-640024-64002016-09-13
008978260020794Sight24-800024-80002016-09-13
008978260021474Sight: Software Package2.06.02-U2016-09-21
00897826002185A-scan Plus Connect: Software Package7.00.02-U2016-09-21
00897826002192B-scan Plus Software Package: Veterinary Version1.03.03-U2016-09-23
00897826002208B-scan Pro Software Package: Veterinary Version4.07.02-U2016-09-23
00897826002222B-scan Plus- VET24-6100-V24-6100-V2016-10-14
00897826002239B-scan Pro- VET24-6400-V24-6400-V2016-10-14
00897826002253Pachpen- VET24-5100-V24-5100-V2016-10-14
00897826002048UBM Plus24-630024-63002016-09-13
00897826002161UBM Plus: Software Package4.07.02-U2016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08683255231881GTK Disposable Needle GuidesGEOTEK MEDIKAL VE SAGLIK HIZMETLERI TICARET SANAYI LIMITED SIRKETIITX2026-10-27
00841517112776Sonosite MTFUJIFILM SONOSITE, INC.IYO2026-10-26
00841517112776Sonosite MTFUJIFILM SONOSITE, INC.ITX2026-10-26
07070554100863Medistim QuickFit TTFM probeMedistim ASAITX2026-10-26
07070554100870Medistim QuickFit TTFM probeMedistim ASAITX2026-10-26
07070554100887Medistim QuickFit TTFM probeMedistim ASAITX2026-10-26
07070554100894Medistim QuickFit TTFM probeMedistim ASAITX2026-10-26
07070554100900Medistim QuickFit TTFM probeMedistim ASAITX2026-10-26
03770033463055FETOLYDIAGNOLYIYO2026-10-22
00198953083246VolusonGE Healthcare Austria GmbH & Co OGIYO2026-10-09
00198953083246VolusonGE Healthcare Austria GmbH & Co OGITX2026-10-09
00198953083253VolusonGE Healthcare Austria GmbH & Co OGITX2026-10-09
00198953083253VolusonGE Healthcare Austria GmbH & Co OGIYO2026-10-09
00198953083260VolusonGE Healthcare Austria GmbH & Co OGITX2026-10-09
00198953083260VolusonGE Healthcare Austria GmbH & Co OGIYO2026-10-09
06948941160022Bladder ScannerMeda Co., LtdITX2026-10-08
06948941160022Bladder ScannerMeda Co., LtdIYO2026-10-08
00855683006821AquaflexPARKER LABORATORIES INCIYO2026-10-01
00855683006845AquaflexPARKER LABORATORIES INCIYO2026-10-01
04719873009510"Esaote MyLabX1" Ultrasound Transducer_Linear ArrayQISDA CORPORATIONITX2026-10-01
04719873009534"Esaote MyLabX1" Ultrasound Transducer_Phased ArrayQISDA CORPORATIONITX2026-10-01
06975424191037Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.ITX2026-10-01
08809887550170EdgeFlow UH10CEdgeCare Inc.ITX2026-09-30
08809887550170EdgeFlow UH10CEdgeCare Inc.IYO2026-09-30
08809887550187EdgeFlow UH10EEdgeCare Inc.ITX2026-09-30
08809887550187EdgeFlow UH10EEdgeCare Inc.IYO2026-09-30
00860007188367FUJIFILMFujifilm Healthcare Americas CorporationIYO2026-09-29
00860007188367FUJIFILMFujifilm Healthcare Americas CorporationITX2026-09-29
00195278985613NAGE Medical Systems (China) Co.,Ltd.IYO2026-09-24
00195278985613NAGE Medical Systems (China) Co.,Ltd.ITX2026-09-24