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

Contact Domains#

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173569000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173569000Ultrasound System 1300Bk Medical Aps2018-02-23IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05704916001285PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05704916001285057049160012855704916001285

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose ultrasound imaging systemA 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
TypeLowHighCondition
Storage Environment Atmospheric Pressure700 millibar1060 millibar
Storage Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4544528100info@bkultrasound.com
+4544528100support@bkmedical.com
+4544528100info@bkmedical.com

Regulatory Flags#

DUNS number
310093901
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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05704916000769Single-Use Endfire Biopsy Guide UA1323-S2016-09-17
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05704916000820Single-Use Needle Guide UA13362016-09-17
05704916000844Single-Use Needle Guide UA13372016-09-17
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05704916000981Single-Use Needle Guide UA13452016-09-17
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05704916001681Non-implantable needle guide, single-useUA1353-SIP2022-12-07
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05704916001612Wireless Remote ControlUA23702025-05-07
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