FDA.reportPublic FDA data

CORE Series Precision Guided Therapy System

Primary DI
00845225010300
Brand
CORE Series Precision Guided Therapy System
Company
Philips Image Guided Therapy Corporation
Model
400-0100.02
Catalog number
400-0100.02
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113486000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113486000VOLCANO S5I INTRAVASCULAR ULTRACOUND IMAGING AND PRESSURE SYSTEMVolcano Corporation2012-01-27IYO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845225010300PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845225010300008452250103008452250103000845225010300

GMDN Terms#

Term, Definition table
TermDefinition
Cardiovascular ultrasound imaging systemAn assembly of mains electricity (AC-powered) devices designed for extracorporeal and/or intracorporeal (endosonography or endoscopic) imaging procedures involving the heart and blood vessels. Included are software packages that support a variety of static or real-time cardiac specific imaging applications used to diagnose anatomical defects of the heart, determine blood flow characteristics and functional/anatomical problems associated with myocardial infarction. It is used to generate ultrasound pulses, direct them to a target area, detect the echoes, and process the resulting information to produce and display static or dynamic two or three-dimensional (3-D) images.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(800) 228-4728IGTD.CustomerInquiry@philips.com

Regulatory Flags#

DUNS number
018860556
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00845225012939IntraSight Plus7974177974172026-05-26
00845225012946IntraSight Plus7974237974232026-05-26
00813132028824StellarexAB35SX040040080AB35SX0400400802022-01-05
00813132028763StellarexAB35SX060100135AB35SX0601001352022-01-13
00813132028770StellarexAB35SX040100135AB35SX0401001352022-01-13
00813132028787StellarexAB35SX040100080AB35SX0401000802022-01-13
00813132028794StellarexAB35SX050100080AB35SX0501000802022-01-13
00813132028800StellarexAB35SX060100080AB35SX0601000802022-01-13
00813132028817StellarexAB35SX050100135AB35SX0501001352022-01-13
00813132028831StellarexAB35SX040080080AB35SX0400800802022-01-13
00813132028848StellarexAB35SX040120080AB35SX0401200802022-01-13
00813132028855StellarexAB35SX050040080AB35SX0500400802022-01-13
00813132028862StellarexAB35SX050080080AB35SX0500800802022-01-13
00813132028879StellarexAB35SX050120080AB35SX0501200802022-01-13
00813132028886StellarexAB35SX060040080AB35SX0600400802022-01-13
00813132028893StellarexAB35SX060080080AB35SX0600800802022-01-13
00813132028909StellarexAB35SX060120080AB35SX0601200802022-01-13
00813132028916StellarexAB35SX040040135AB35SX0400401352022-01-13
00813132028923StellarexAB35SX040080135AB35SX0400801352022-01-13
00813132028930StellarexAB35SX040120135AB35SX0401201352022-01-13

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Primary DI, Brand, Company table
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00841517112035iLOOKFUJIFILM SONOSITE, INC.IYO2026-07-16
00841517112462iLOOKFUJIFILM SONOSITE, INC.IYO2026-07-16
00841517139018iLOOKFUJIFILM SONOSITE, INC.IYO2026-07-16
00860013043605EdgeLife TechnologiesEdge Life Technologies, LLCIYO2026-07-10
00860013043612EdgeLife TechnologiesEdge Life Technologies, LLCIYO2026-07-10
06938396440008SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IYO2026-07-10
00841517112653rP19x/5-1 MHz ArmoredFUJIFILM SONOSITE, INC.IYO2026-06-24
00841517112660L12-3FUJIFILM SONOSITE, INC.IYO2026-06-24
00841517112677L15-4FUJIFILM SONOSITE, INC.IYO2026-06-24
00852619008041QT Scanner 2000Qt Imaging, Inc.IYO2026-06-24
00841517112646L15-4FUJIFILM SONOSITE, INC.IYO2026-06-23
00841517112639L12-3FUJIFILM SONOSITE, INC.IYO2026-06-22
00198953078716LOGIQGE Medical Systems (China) Co.,Ltd.IYO2026-06-10
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00850050934264EndoSound® EVS SideBeam 5105 (4 pouches)Endosound, Inc.IYO2026-06-01
04987670105937DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.IYO2026-06-01
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00198953121382VolusonGE Ultrasound Korea Ltd.IYO2026-05-28
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08056304455833MyLabC30ESAOTE SPAIYO2025-12-10
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