FDA.reportPublic FDA data

Foresight ICE™ PIM

Primary DI
00628055603047
Brand
Foresight ICE™ PIM
Company
Conavi Medical Inc
Model
TA-02-0001
Device description
Imaging system
Published
2020-09-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQOCatheter, Intravascular, Diagnostic
ITXTransducer, Ultrasonic, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQOCatheter, Intravascular, DiagnosticCardiovascular2
ITXTransducer, Ultrasonic, DiagnosticRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162789000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162789000Foresight Intracardiac Echocardiology (ICE) SystemConavi Medical, Inc.2017-03-28DQO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00628055603047PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628055603047006280556030476280556030470628055603047

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
416-483-0100customerservice@conavi.com

Regulatory Flags#

DUNS number
200125243
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628055603115Novasight Hybrid™ CatheterTA-06-00012023-04-17
00628055603054Novasight Hybrid™ CatheterTA-06-00012020-09-09
00628055603092Novasight Hybrid™ PIMTA-07-00022022-10-25
00628055603016Foresight ICE™ CatheterTA-01-00012020-09-11
01628055603015Foresight ICE™ CatheterTA-01-00012020-09-11
00628055603023Foresight ICE™ Catheter Accessories PackageSA-01-00152020-09-11
00628055603030Foresight ICE™ Hummingbird ConsoleTA-03-00012020-09-11
00628055603061Novasight Hybrid™ Catheter Accessories PackageSA-10-00222020-09-11
00628055603078Novasight Hybrid™ Hummingbird ConsoleTA-03-00052020-09-11
00628055603085Novasight Hybrid™ PIMTA-07-00012020-09-11
00628055603108Novasight Hybrid™ Catheter PIM BagSA-10-00292020-09-11
01628055603053Novasight Hybrid™ CatheterTA-06-00012020-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450787663Impress®Merit Medical Systems, Inc.DQO2026-06-08
00850050934233EndoSound® EVS ProbeEndosound, Inc.ITX2026-06-01
04987670105937DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.ITX2026-06-01
04987670106194DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.ITX2026-06-01
00885403522270Swan-GanzBecton, Dickinson And CompanyDQO2026-05-30
00885403522386Swan-GanzBecton, Dickinson And CompanyDQO2026-05-30
08800013510112L8-17HAlpinion Medical Systems Co., Ltd.ITX2026-05-29
00198953121382VolusonGE Ultrasound Korea Ltd.ITX2026-05-28
00884450766958Performa®Merit Medical Systems, Inc.DQO2026-05-28
08056304455826MyLabC25ESAOTE SPAITX2025-12-10
08056304455833MyLabC30ESAOTE SPAITX2025-12-10
08056304455017MyLabA50ESAOTE SPAITX2025-07-07
08056304455215MyLabE85ESAOTE SPAITX2025-07-07
08056304455307MyLabA70ESAOTE SPAITX2025-07-07
08056304455437MyLabA50ESAOTE SPAITX2025-07-07
08056304455451MyLabA70ESAOTE SPAITX2025-07-07
08056304455635MyLabE80ESAOTE SPAITX2025-07-07
08056304455642MyLabE85ESAOTE SPAITX2025-07-07
00850055427075HYDROS TRUS ProbePROCEPT BioRobotics CorporationITX2024-09-06
08056304455628MyLabE80ESAOTE SPAITX2024-03-29
04573596212318S3ESCLSFUJIFILM CORPORATIONITX2024-01-25
08056304454980MyLabX90ESAOTE SPAITX2023-12-14
08056304454676MyLabX9ESAOTE SPAITX2023-06-13
08033737713037THD Procto Software SystemTHD SPAITX2021-07-19
04573596212325S3ESELFUJIFILM CORPORATIONITX2021-07-18
07613327313956Trevo Trak 21Stryker CorporationDQO2020-04-17
08056304453891E 3-12ESAOTE SPAITX2019-12-20
08056304454096C 2-9ESAOTE SPAITX2019-12-20
08056304453518MyLabX6ESAOTE SPAITX2019-06-13
08056304453525MyLabX7ESAOTE SPAITX2019-06-13