FDA.reportPublic FDA data

Enovare

Primary DI
08638750003013
Brand
Enovare
Company
OREON TECHNOLOGIES INC.
Model
4001001
Device description
diagnostic ultrasound system
Published
2018-01-03
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08638750003013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08638750003013086387500030138638750003013

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

Contacts#

Phone, Email table
PhoneEmail
19144130087howard@enovare.net

Regulatory Flags#

DUNS number
054353531
Device count
1
DM exempt
true
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
true
Sterilization required before use
false

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00845225012939IntraSight PlusPhilips Image Guided Therapy CorporationIYO2026-05-26
00845225012946IntraSight PlusPhilips Image Guided Therapy CorporationIYO2026-05-26
06974405095104CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.IYO2026-05-26
06974405095159CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.IYO2026-05-26
06974405095166CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.IYO2026-05-26
D510DUS6000ADVANCED DIGITAL PORTABLE ULTRASONIC SYSTEM ADVANCED INSTRUMENTATIONS, INC.IYO2026-03-24
10841716103992ACIST HDi™ CartACIST MEDICAL SYSTEMS, INC.IYO2026-03-04
04987670102813DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.IYO2026-03-01
06975345060108Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.IYO2026-01-31
16978669290012Astrasono A5Pro Bladder ScannerAstrasono technology co.,ltd.IYO2026-01-15
20841436126346Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2025-12-31
00198953042816LOGIQGe Medical Systems, Ultrasound & Primary Care Diagnostics LlcIYO2025-12-05
00841517112141Sonosite MTFUJIFILM SONOSITE, INC.IYO2025-11-24
00841517112196Sonosite MTFUJIFILM SONOSITE, INC.IYO2025-11-24
16978669290005Astrasono A3Pro Bladder ScannerAstrasono technology co.,ltd.IYO2025-11-20
00198953001431Venue GoGe Medical Systems, Ultrasound & Primary Care Diagnostics LlcIYO2025-11-17
00198953079256VscanGE Vingmed Ultrasound ASIYO2025-11-17
00845225012984Patient Interface Module (PIMr)Philips Image Guided Therapy CorporationIYO2025-08-22
06971679948945Shear Wave Quantificational Ultrasound Diagnostic SystemWuxi Hisky Medical Technologies Co.,Ltd.IYO2025-08-05
00198953001073VenueGe Medical Systems, Ultrasound & Primary Care Diagnostics LlcIYO2025-07-31
00198953001097Venue GoGe Medical Systems, Ultrasound & Primary Care Diagnostics LlcIYO2025-07-31
06938396400484SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IYO2025-07-21
06938396400965SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IYO2025-07-21
06938396400972SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IYO2025-07-21
06938396400989SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IYO2025-07-21
06938396400996SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IYO2025-07-21
06938396401016SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IYO2025-07-21
06938396401023SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IYO2025-07-21
06938396401030SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IYO2025-07-21
06938396401047SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IYO2025-07-21