EchoGo

Primary DI
05060634690065
Brand
EchoGo
Company
ULTROMICS LIMITED
Model
Amyloidosis 1.0
Published
2024-12-17
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
SDJAdjunctive Cardiac Amyloidosis Status Indicator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SDJAdjunctive Cardiac Amyloidosis Status IndicatorCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240860000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240860000EchoGo Amyloidosis (1.0)Ultromics Limited2024-11-15SDJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060634690065PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060634690065050606346900655060634690065

GMDN Terms#

Term, Definition table
TermDefinition
Radiology DICOM image processing application softwareA software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/disc burning) and/or image quality manipulation and quantification (e.g., non-interpretive graphical overlays).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
222850684
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060634690072EchoGoWorkstream 1.02026-01-14
05060634690058EchoGoHeart Failure 2.02024-12-17
05060634690041EchoGoHeart Failure 1.02023-02-15
05060634690027EchoGoCore 2.02022-01-19
05060634690003EchoGo Core2020-10-16
05060634690010EchoGoPro2021-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860005876891Us2.caEKO.AI PTE. LTD.SDJ2026-04-20