FDA.reportPublic FDA data

Exo Iris

Primary DI
00850018318006
Brand
Exo Iris
Company
Exo Imaging, Inc.
Model
EI2001
Device description
Exo Iris is a hand-held, general-purpose diagnostic imaging system.
Published
2023-12-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
K222198000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222198000Exo Iris (El2001)Exo Imaging, Inc.2022-11-09IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850018318006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850018318006008500183180068500183180060850018318006

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held ultrasound imaging system, body-surfaceA battery-powered, hand-held device/device assembly designed to be placed over the external body surface for collection, display, and analysis of ultrasound information during a variety of ultrasound imaging procedures (i.e., non-dedicated); it may in addition be intended to be used with a sterile cover for intraoperative imaging. It consists of a flat- or concave-lensed ultrasound transducer and includes an integrated image processing system; it may include an integrated display or be intended to wirelessly transmit images to an off-the-shelf device (e.g., smartphone, tablet) with dedicated software installed. It is not designed to be inserted into the vagina or rectum.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080615046
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850018318068Exo Iris Ultrasound SystemEI20012023-12-22
00850018318013Exo Works EW10012022-12-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800010500840SonoSync+SAMSUNG MEDISON CO., LTD.IYO2026-08-18
08800010500840SonoSync+SAMSUNG MEDISON CO., LTD.IYN2026-08-18
08800290029376CA2-13MSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800290036169PA2-9SSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800290036237BCC2-13SAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800357291937V6 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYN2026-08-18
08800357291937V6 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-08-18
08800357291937V6 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800357300165V7 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYN2026-08-18
08800357300165V7 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800357300165V7 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-08-18
08800357308208V8 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800357308208V8 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-08-18
08800357308208V8 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYN2026-08-18
00841517112684C5-1FUJIFILM SONOSITE, INC.IYO2026-08-07
00841517112684C5-1FUJIFILM SONOSITE, INC.ITX2026-08-07
00841517112684C5-1FUJIFILM SONOSITE, INC.IYN2026-08-07
00195278439352LOGIQGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCIYO2025-12-05
00195278439352LOGIQGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCIYN2025-12-05
00195278439369LOGIQGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCIYO2025-12-05
00195278439369LOGIQGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCIYN2025-12-05
00195278723963NAGE Healthcare Japan CorporationIYN2025-10-15
00195278723963NAGE Healthcare Japan CorporationITX2025-10-15
00195278723963NAGE Healthcare Japan CorporationIYO2025-10-15
00195278875860VscanGE Vingmed Ultrasound A/SITX2025-07-04
00195278875860VscanGE Vingmed Ultrasound A/SIYN2025-07-04
00195278875860VscanGE Vingmed Ultrasound A/SIYO2025-07-04
00195278910509VolusonGE Ultrasound Korea Ltd.ITX2025-06-04
00195278910509VolusonGE Ultrasound Korea Ltd.IYN2025-06-04
00195278910509VolusonGE Ultrasound Korea Ltd.IYO2025-06-04