FDA.reportPublic FDA data

CombiDiagnost R90

Primary DI
00884838101456
Brand
CombiDiagnost R90
Company
Philips Medical Systems DMC GmbH
Model
709031
Device description
The CombiDiagnost R90 is a multi-functional general Radiography/Fluoroscopy (R/F) system.that includes- Adjustable Straps for Patient Support; - Adult headrest;- Ankle Clamps;- Arm Support;- Babix holder vertical stand;- Compression Belt (singles. pull);- Console trolles;- Detector Holder for Patient Bed;- Extra Stitching Ruler;- Hand grips (Pair of);- Handle;- Infusion bottle holder;- Leg Supports (Pair of);- Mattress GXR Systems;- Mobile Detector Holder;- Monitor Ceiling Suspension(Family);- Monitor CS for1 Monitor;- Monitor CS for2 Monitors;- Monitor CS for3 Monitors;- Monitor Trolley Family:- Monitor Trolley for 1 Monitor assembly;- Monitor Trolley for 2 Monitors assembly;- Patient Support for Stitching;- Rotable stool for footrest;- Shoulder supports (Pair of);- Side Bar;- Stretch Grip for VS/VM Stand
Published
2021-02-04
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
JAASystem, x-ray, fluoroscopic, image-intensified

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAASystem, X-Ray, Fluoroscopic, Image-IntensifiedRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203087000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203087000CombiDiagnost R90Philips Medical Systems Dmc GmbH2020-12-03JAA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838101456PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838101456008848381014568848381014560884838101456

GMDN Terms#

Term, Definition table
TermDefinition
Indirect flat panel x-ray detectorAn electrically-powered, cassette-like device intended to be used as part of an x-ray system to detect x-ray images following exposure, and create a digital signal; it is not dedicated to imaging of a specific anatomy. It includes two types of transducing technology (i.e., indirect): a scintillator [e.g. caesium iodide (CsI)] screen converts x-ray energy into light, followed by the conversion of light into a digital signal by photodiode array. The image data can be sent to an appropriate processing unit through a wired or wireless connection (e.g., Wi-Fi). It may be used in place of a fixed detector in x-ray imaging systems, e.g., as part of a digital imaging conversion system.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure70 KiloPascal110 KiloPascal
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)722-9377xx@xx.xx

Regulatory Flags#

DUNS number
314101218
Device count
1
Combination product
true
Serial number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884838115521Radiography 7000 M7120102024-02-22
00884838116016Radiography 7300 C7120372024-06-27
00884838103221ProxiDiagnost N907061102022-01-17
00884838090699DigitalDiagnost C907120342019-03-28
00884838090705DigitalDiagnost C907120352019-03-28
00884838065321DigitalDiagnost7120317120312016-09-19
00884838074514DigitalDiagnost7120327120322016-09-19
00884838074521DigitalDiagnost7120337120332016-09-19
00884838102842Telemetry Monitor 5500 1.4 GHz RadioTelemetry Monitor 5500 1.4 GHz Radio8672322026-04-27
00884838076747CombiDiagnost R907090307090302018-05-09
00884838127517CT XS Tube CPO9806-058-000919806-058-000912025-07-31
00884838125322Grid Landscape for SkyPlate E 9896-010-725122025-06-19
00884838125339Grid Landscape for SkyPlate large 9896-010-686242025-06-19
00884838125346Grid Portrait for SkyPlate E 9896-010-725022025-06-19
00884838125353Grid Portrait for SkyPlate large9896-010-686332025-06-19
00884838125360Grid Portrait for SkyPlate small 9896-010-686442025-06-19
00884838125384Grid Portrait Fiber PaxScan4336W9896-010-708322025-06-19
00884838125391Grid Landscape Fiber PaxScan4336W9896-010-708222025-06-19
00884838125421X-Ray Grid 40/12/1409896-010-648922025-06-19
00884838125438X-Ray Grid 40/12/180 9896-010-646722025-06-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B225100000220Orthoscan TAU MVP 1515Ziehm-Orthoscan, Inc.JAA2026-04-30
B225100000230Orthoscan TAU MVP 2020Ziehm-Orthoscan, Inc.JAA2026-04-30
08809244060533GenorayGENORAY CO., LTD.JAA2026-04-10
08809244060557GenorayGENORAY CO., LTD.JAA2026-04-10
08809244060632GenorayGENORAY CO., LTD.JAA2026-04-10
00198953052488AlliaGE MEDICAL SYSTEMSJAA2025-12-17
08809244060618GenorayGENORAY CO., LTD.JAA2025-12-01
08809244060625GenorayGENORAY CO., LTD.JAA2025-12-01
08809244060700GenorayGENORAY CO., LTD.JAA2025-12-01
08800018422601EXTRON 3DRTECH CorporationJAA2025-06-17
08809244060090GenorayGENORAY CO., LTD.JAA2025-05-02
00643169618121O-armMEDTRONIC NAVIGATION, INC.JAA2024-10-10
00195451000799Shockwave IVL System with the Shockwave Javelin Peripheral IVL CatheterShockwave Medical, Inc.JAA2024-10-09
00190376601182IntraOp Alignment SystemALPHATEC SPINE, INC.JAA2024-10-01
00193982184506EXCELSIUS3DGLOBUS MEDICAL, INC.JAA2024-06-26
00193982184537EXCELSIUS3DGLOBUS MEDICAL, INC.JAA2024-06-26
00195451000539Shockwave IVL System with the Shockwave E8 Peripheral IVL CatheterShockwave Medical, Inc.JAA2024-04-17
00195451000546Shockwave IVL System with the Shockwave E8 Peripheral IVL CatheterShockwave Medical, Inc.JAA2024-04-17
00195451000553Shockwave IVL System with the Shockwave E8 Peripheral IVL CatheterShockwave Medical, Inc.JAA2024-04-17
00195451000560Shockwave IVL System with the Shockwave E8 Peripheral IVL CatheterShockwave Medical, Inc.JAA2024-04-17
00195451000577Shockwave IVL System with the Shockwave E8 Peripheral IVL CatheterShockwave Medical, Inc.JAA2024-04-17
00195451000584Shockwave IVL System with the Shockwave E8 Peripheral IVL CatheterShockwave Medical, Inc.JAA2024-04-17
00195278719720AlliaGE MEDICAL SYSTEMSJAA2023-12-08
08800018420805EXTRON 5DRTECH CorporationJAA2023-08-24
08800018420904EXTRON 7DRTECH CorporationJAA2023-08-24
00195451000386Shockwave IVL System with the Shockwave L6 Peripheral IVL CatheterShockwave Medical, Inc.JAA2022-10-24
00195451000393Shockwave IVL System with the Shockwave L6 Peripheral IVL CatheterShockwave Medical, Inc.JAA2022-10-24
00195451000409Shockwave IVL System with the Shockwave L6 Peripheral IVL CatheterShockwave Medical, Inc.JAA2022-10-24
00195451000416Shockwave IVL System with the Shockwave L6 Peripheral IVL CatheterShockwave Medical, Inc.JAA2022-10-24
00195278524904OptimaGE Hualun Medical Systems Co., LtdJAA2022-10-20