FDA.reportPublic FDA data

KOLO

Primary DI
06975170000010
Brand
KOLO
Company
Kolo Medical (Suzhou) Co., Ltd.
Model
Evolution XHD 50
Device description
Ultrasound Diagnostic System
Published
2022-10-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K221568000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221568000KOLO Evolution XHD Series Ultrasound Diagnostic SystemKolo Medical (Suzhou) Co., Ltd.2022-09-12IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975170000010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975170000010069751700000106975170000010

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
550397899
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975170000027KOLOEvolution XHD 552022-10-27
06975170000034KOLOEvolution XHD 602022-10-27
06975170000041KOLOEvolution XHD 652022-10-27
06975170000058KOLOEvolution XHD 702022-10-27
06975170000065KOLOEvolution XHD 802022-10-27
06975170000072KOLOL22-8K22022-10-27
06975170000089KOLOL38-22K22022-10-27
06975170000102KOLOL62-38K22022-10-27
06975170000119KOLOL28-12K22022-10-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00860013043605EdgeLife TechnologiesEdge Life Technologies, LLCIYO2026-07-10
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00860013043612EdgeLife TechnologiesEdge Life Technologies, LLCITX2026-07-10
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00841517112653rP19x/5-1 MHz ArmoredFUJIFILM SONOSITE, INC.IYN2026-06-24
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