FDA.reportPublic FDA data

Incisive CT

Primary DI
00884838105508
Brand
Incisive CT
Company
Philips Healthcare (Suzhou) Co., Ltd.
Model
Incisive CT
Catalog number
728144
Device description
The Incisive CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Published
2021-12-30
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
JAKSystem, X-Ray, Tomography, Computed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAKSystem, X-Ray, Tomography, ComputedRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180015000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180015000Philips Incisive CTPhilips Healthcare (Suzhou) Co., Ltd.2018-03-20JAK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838105508PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838105508008848381055088848381055080884838105508

GMDN Terms#

Term, Definition table
TermDefinition
Full-body CT systemAn assembly of diagnostic x-ray computed tomography (CT) devices with a gantry large enough to allow imaging of any part of the body. It includes designs with single or multiple fixed annular arrays of x-ray tubes and opposing detectors or those with x-ray tube(s) and opposing detector assemblies that rotate rapidly around a central axis point within the gantry imaging area. It can produce two and/or three-dimensional (3-D) cross-sectional (tomographic) images, including spiral CT or other special imaging applications at multiple specified angles in relation to body position. It may use a variety of digital techniques for information capture, image reconstruction, and display.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Handling Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature-20 Degrees Celsius50 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature-15 Degrees Celsius45 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8007229377shiguang.an@philips.com

Regulatory Flags#

DUNS number
421265537
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884838121430Incisive CT and CT 5300 UpgradesIncisive CT and CT 5300 Upgrades7282862026-08-21
00884838129559CT Areta RT/Rembra RT UpgradesCT Areta RT/Rembra RT Upgrades7283852026-08-21
00884838129528CT RembraCT Rembra7283832026-04-03
00884838129535CT Rembra RTCT Rembra RT7283812026-04-03
00884838129542CT Areta RTCT Areta RT7283822026-04-03
00884838113237CT 5300CT 53007282852024-11-11
00884838111622Smart Fit Shoulder 1.5TSmart Fit Shoulder 1.5T9897100121912026-06-26
00884838112667Smart Fit Knee 3.0TSmart Fit Knee 3.0T9897100122512026-06-26
00884838131866Smart Fit TorsoCardiac 1.5TSmart Fit TorsoCardiac 1.5T9897100121622026-06-26
00884838133235dS MSK M 1.5TdS MSK M 1.5T4598016820132026-06-26
00884838133242dS MSK S 1.5TdS MSK S 1.5T4598016820032026-06-26
00884838085015Incisive CTIncisive CT7281432019-10-01
00884838096813dS TorsoCardiac 1.5TdS TorsoCardiac 1.5T45980168199X2022-04-17
00884838096837dS MSK M 1.5TdS MSK M 1.5T45980168201X2022-04-17
00884838096820dS MSK S 1.5TdS MSK S 1.5T45980168200X2022-04-17
00884838095199DigitalDiagnost C50DigitalDiagnost C507122042020-09-04
00884838095205DuraDiagnostDuraDiagnost7122032020-09-04
00884838064737DuraDiagnost CompactDuraDiagnost Compact7122132016-09-23
00884838064751DuraDiagnostDuraDiagnost7122142016-09-23
00884838082366DigitalDiagnost C50DigitalDiagnost C507122012017-10-26

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10884521837157ILLUMISITECovidien LPJAK2024-08-09
10884521842915ILLUMISITECovidien LPJAK2024-08-09
07640167220021CAS-One IR Consumable Set GeneralCAScination AGJAK2024-06-17
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