FDA.report

IntraSight Plus

Primary DI
00845225012946
Brand
IntraSight Plus
Company
Philips Image Guided Therapy Corporation
Model
797423
Catalog number
797423
Device description
The IntraSight Plus is an interventional applications workspace.
Published
2026-05-26
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
DSACable, Transducer And Electrode, Patient, (Including Connector)
DSKComputer, Blood-Pressure
IYOSystem, Imaging, Pulsed Echo, Ultrasonic
OWBInterventional Fluoroscopic X-Ray System

Product Code Classifications

CodeDeviceSpecialtyClass
DSACable, Transducer And Electrode, Patient, (Including Connector)Cardiovascular2
DSKComputer, Blood-PressureCardiovascular2
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2
OWBInterventional Fluoroscopic X-Ray SystemRadiology2

Premarket Submissions

SubmissionSupplement
K253714000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K253714000IntraSight PlusPhilips Image Guided Therapy Corporation2026-02-24IYO

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00845225012946PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00845225012946008452250129468452250129460845225012946

GMDN Terms

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.

Storage And Handling

TypeLowHighCondition
Storage Environment Atmospheric Pressure00
Storage Environment Humidity00
Storage Environment Temperature00

Contacts

PhoneEmail
(800) 228-4728IGTD.CustomerInquiry@philips.com

Regulatory Flags

DUNS number
118354223
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

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20813132029436Quick-Cross Extreme518-088-B518-0882023-10-04
20813132029443Quick-Cross Extreme518-090-B518-0902023-10-04
20813132029450Quick-Cross Extreme518-092-B518-0922023-10-04
00813132029463Quick-Cross Extreme518-076-B518-0762023-10-04
20813132029474Quick-Cross Extreme518-078-B518-0782023-10-04
20813132029481Quick-Cross Extreme518-080-B518-0802023-10-04
20813132029498Quick-Cross Extreme518-082-B518-0822023-10-04
20813132029511Quick-Cross Select518-085-B518-0852023-10-04
20813132029528Quick-Cross Select518-087-B518-0872023-10-04
20813132029535Quick-Cross Select518-089-B518-0892023-10-04
20813132029542Quick-Cross Select518-091-B518-0912023-10-04
20813132029559Quick-Cross Select518-093-B518-0932023-10-04

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Primary DIBrandCompanyProduct codePublished
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00845225012939IntraSight PlusPhilips Image Guided Therapy CorporationDSK2026-05-26
00845225012939IntraSight PlusPhilips Image Guided Therapy CorporationIYO2026-05-26
00845225012939IntraSight PlusPhilips Image Guided Therapy CorporationDSA2026-05-26
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