FDA.reportPublic FDA data

DuraDiagnost

Primary DI
00884838064751
Brand
DuraDiagnost
Company
Philips Healthcare (Suzhou) Co., Ltd.
Model
DuraDiagnost
Catalog number
712214
Device description
The DuraDiagnost is intended for use in generating radiographic images of human anatomy by qualified/trained doctor or technician. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This device is not intended for mammographic applications.
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KPRSystem, x-ray, stationary
MQBSolid state x-ray imager (flat panel/digital imager)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPRSystem, X-Ray, StationaryRadiology2
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)Radiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838064751PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838064751008848380647518848380647510884838064751

GMDN Terms#

Term, Definition table
TermDefinition
Stationary basic diagnostic x-ray system, digitalAn assembly of devices that comprise general-purpose stationary diagnostic x-ray system used in a variety of routine planar x-ray imaging applications. It uses digital techniques for image capture, display and manipulation. The stationary design requires it to be installed and used in a fixed location within a building or in a transportation van (a mobile imaging van). This system consists of modular configurations that can be upgraded by the addition of hardware/software components. This GMDN code does not cover systems with fluoroscopic or tomographic capabilities.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure00
Handling Environment Humidity00
Handling Environment Temperature00
Storage Environment Atmospheric Pressure00
Storage Environment Humidity00
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+1(800)722-9377shawn.guo@philips.com

Regulatory Flags#

DUNS number
421265537
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884838133235dS MSK M 1.5TdS MSK M 1.5T4598016820132026-06-26
00884838133242dS MSK S 1.5TdS MSK S 1.5T4598016820032026-06-26
00884838064737DuraDiagnost CompactDuraDiagnost Compact7122132016-09-23
00884838082366DigitalDiagnost C50DigitalDiagnost C507122012017-10-26
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
00884838121430Incisive CT and CT 5300 UpgradesIncisive CT and CT 5300 Upgrades7282862026-08-21
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
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
00884838105508Incisive CTIncisive CT7281442021-12-30
00884838095199DigitalDiagnost C50DigitalDiagnost C507122042020-09-04
00884838095205DuraDiagnostDuraDiagnost7122032020-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860014490170AspenFDRAspen Imaging Healthcare IncKPR2026-09-08
00860014490187AspenXDRAspen Imaging Healthcare IncKPR2026-09-08
00854810007007AirDRIcRco, Inc.MQB2026-07-22
00854810007014AirDRIcRco, Inc.MQB2026-07-22
00854810007120iDRIcRco, Inc.MQB2026-07-22
00854810007205AirDRIcRco, Inc.MQB2026-07-22
08809394330906VIVIX-S 4386WVIEWORKS CO., LTD.MQB2026-07-16
06938396401528SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401559SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401566SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401597SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401603SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401634SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401658SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401702SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401719SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396410124SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
08800017000107DRE DuoJPI HEALTHCARE. CO., LTD.KPR2026-07-03
08800017000114DRE DuoJPI HEALTHCARE. CO., LTD.KPR2026-07-03
08800017000121DRE DuoJPI HEALTHCARE. CO., LTD.KPR2026-07-03
08800017000138DRE DuoJPI HEALTHCARE. CO., LTD.KPR2026-07-03
08683161912041GR10XXERA TEKNOLOJI VE YAZILIM LIMITED SIRKETIKPR2026-06-22
08683161912058GR10XXERA TEKNOLOJI VE YAZILIM LIMITED SIRKETIKPR2026-06-22
08057737122040Villa Sistemi MedicaliVILLA SISTEMI MEDICALI SPAMQB2026-06-04
08057737122057Villa Sistemi MedicaliVILLA SISTEMI MEDICALI SPAMQB2026-06-04
08055186671089A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLMQB2026-04-02
00195278913807DefiniumGE Hualun Medical Systems Co., LtdMQB2024-10-30
00195278913807DefiniumGE Hualun Medical Systems Co., LtdKPR2024-10-30
00195278832252NAGE Hualun Medical Systems Co., LtdKPR2024-07-01
00195278832252NAGE Hualun Medical Systems Co., LtdMQB2024-07-01