FDA.reportPublic FDA data

EndoSound® EVSScanner

Primary DI
00850050934028
Brand
EndoSound® EVSScanner
Company
Endosound, Inc.
Model
5000
Catalog number
5000
Device description
The EndoSound Vision System (EVS) Scanner is a small, portable, self-contained module that contains the electronics that perform ultrasound scanning and receiving functions (beamforming).
Published
2024-01-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
ODGEndoscopic Ultrasound System, Gastroenterology-Urology

Product Code Classifications

CodeDeviceSpecialtyClass
ODGEndoscopic Ultrasound System, Gastroenterology-UrologyGastroenterology, Urology2

Premarket Submissions

SubmissionSupplement
K232518000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K232518000EndoSound Vision System; EVSEndosound, Inc.2023-12-27ODG

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850050934028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850050934028008500509340288500509340280850050934028

GMDN Terms

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

TypeLowHighCondition
Handling Environment Atmospheric Pressure75 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature-10 Degrees Celsius60 Degrees Celsius
Storage Environment Atmospheric Pressure75 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius60 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
(971) 231-4791info@endosound.com

Regulatory Flags

DUNS number
111281644
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00850050934165EndoSound® Ultrasound Transducer Module (UTM)501650162024-10-31
10850050934186EndoSound® EVS™ Band Applicator501250122024-08-30
00850050934141EndoSound® EVS™ Bands1810250132024-06-14
00850050934011EndoSound® Transducer Extension Connector (TEC)500250022024-01-30
00850050934035EndoSound® Ultrasound Transducer Module (UTM)500150012024-01-30
00850050934042EndoSound® Ultrasound Disposable Kit (UDK-T) 5004500450032024-01-30
00850050934080EndoSound® Ultrasound Disposable Kit (UDK-T) 5006500650052024-01-30
00850050934097EndoSound® Ultrasound Disposable Kit (UDK-T) 5010501050092024-01-30
00850050934103EndoSound® Ultrasound Disposable Kit (UDK-T) 5008500850072024-01-30
00850050934110EndoSound® Air Leak Tester503050302024-01-30
00850050934127EndoSound® Vision System (EVS) Software501150112024-01-30

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