Home GUDID 05704916001285
bkSpecto Ultrasound System
Primary DI 05704916001285
Brand bkSpecto Ultrasound System
Company BK MEDICAL APS
Model 1300
Catalog number 1300
Device description The 1300 Ultrasound Scanner is a multi-purpose mobile, software controlled diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. It includes the following scanning modes: B, B+M, B+D, B+C, B+D+C . (D is PWD, C is Color Flow mapping Doppler including Velocity and Variance display, Amplitude(power)Doppler including directional display ). B mode includes Tissue Harmonic Imaging , VFI (Vector Flow Imaging), Elastography, Contrast Imaging, CW doppler. The system performs simple geometric measurements and calculations in the following areas: Urology, Vascular, Cardiology, OB/GYN, Emergency Medicine, Surgery, and Anesthesia. Optional 3-D unit can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen.
Published 2018-07-12
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Product Codes# Code, Name table Code Name ITX Transducer, Ultrasonic, Diagnostic IYN System, Imaging, Pulsed Doppler, Ultrasonic IYO System, Imaging, Pulsed Echo, Ultrasonic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ITX Transducer, Ultrasonic, Diagnostic Radiology 2 IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology 2 IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05704916001285 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05704916001285 05704916001285 5704916001285
GMDN Terms# Term, Definition table Term Definition General-purpose ultrasound imaging system A stationary or mobile (e.g., on wheels) assembly of devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures (e.g., cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical imaging). It consists of a mains (AC-powered) data processing unit with integrated software and a monitor. It is typically presented as a mobile assembly which may support a wide variety of transducers and related application software packages; an ultrasound transducer(s) may be included.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Atmospheric Pressure 700 millibar 1060 millibar Storage Environment Humidity 20 Percent (%) Relative Humidity 80 Percent (%) Relative Humidity Storage Environment Temperature -20 Degrees Celsius 60 Degrees Celsius
Regulatory Flags# DUNS number 310093901 Device count 1 Serial number true Manufacturing date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 06903053124348 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYN 2026-06-03 06903053124355 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYN 2026-06-03 06903053124379 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYN 2026-06-03 06903053124430 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYN 2026-06-03 06903053124461 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYN 2026-06-03 06903053124492 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYN 2026-06-03 06903053124546 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYN 2026-06-03 06903053124560 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYN 2026-06-03 06903053124591 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYN 2026-06-03 06903053124607 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYN 2026-06-03 06903053124614 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYN 2026-06-03 06903053124683 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYN 2026-06-03 06903053124706 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYN 2026-06-03 06903053124720 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYN 2026-06-03 06903053124775 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYN 2026-06-03 06903053124829 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYN 2026-06-03 00850050934233 EndoSound® EVS Probe Endosound, Inc. ITX 2026-06-01 00850050934240 EndoSound® EVS SideBeam 5103 Endosound, Inc. IYO 2026-06-01 00850050934240 EndoSound® EVS SideBeam 5103 Endosound, Inc. IYN 2026-06-01 00850050934257 EndoSound® Coax Transducer Extension Connector (TEC) Endosound, Inc. IYO 2026-06-01 00850050934257 EndoSound® Coax Transducer Extension Connector (TEC) Endosound, Inc. IYN 2026-06-01 00850050934264 EndoSound® EVS SideBeam 5105 (4 pouches) Endosound, Inc. IYO 2026-06-01 00850050934264 EndoSound® EVS SideBeam 5105 (4 pouches) Endosound, Inc. IYN 2026-06-01 04987670105937 DIAGNOSTIC ULTRASOUND SYSTEM CANON INC. ITX 2026-06-01 04987670105937 DIAGNOSTIC ULTRASOUND SYSTEM CANON INC. IYO 2026-06-01 04987670105937 DIAGNOSTIC ULTRASOUND SYSTEM CANON INC. IYN 2026-06-01 04987670106194 DIAGNOSTIC ULTRASOUND SYSTEM CANON INC. ITX 2026-06-01 04987670106194 DIAGNOSTIC ULTRASOUND SYSTEM CANON INC. IYN 2026-06-01 04987670106194 DIAGNOSTIC ULTRASOUND SYSTEM CANON INC. IYO 2026-06-01 08800013510112 L8-17H Alpinion Medical Systems Co., Ltd. IYN 2026-05-29