FDA.reportPublic FDA data

Philips Radiology Smart Assistant

Primary DI
00884838104013
Brand
Philips Radiology Smart Assistant
Company
Philips Medical Systems DMC GmbH
Model
1.0
Catalog number
30000581513X
Published
2022-01-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JAASystem, X-Ray, Fluoroscopic, Image-Intensified
KPRSystem, X-Ray, Stationary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAASystem, X-Ray, Fluoroscopic, Image-IntensifiedRadiology2
KPRSystem, X-Ray, StationaryRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212186000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212186000Philips Radiology Smart AssistantPhilips Medical Systems Dmc GmbH2021-12-13KPR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838104013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838104013008848381040138848381040130884838104013

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic x-ray digital imaging system workstation application softwareAn individual software application program or group of programs, routines or algorithms that add specific computer assisted display, processing and/or analysis capabilities to a diagnostic x-ray system workstation so that it may function according to its intended purpose, e.g., for the rendering, visualization and manipulation of medical images to support the image display needs of clinicians, diagnosticians and technicians. A basic set of applications programs and routines are included with the multi-purpose diagnostic x-ray system workstation and can be upgraded to correct programming errors or to add new system capabilities.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
314101218
Device count
1
Serial number
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
00884838101456CombiDiagnost R907090312021-02-04
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04547410582901FDR CROSS SlimFUJIFILM CORPORATIONJAA2026-08-14
00854810007199iXRSIcRco, Inc.JAA2026-07-22
00860014944611nView s1 with nav optionNVIEW MEDICAL INC.JAA2026-07-08
00680211003276PREFERRED MEDICAL PRODUCTS LLCPREFERRED MEDICAL PRODUCTS, LLCJAA2026-07-06
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
00848340021879Mitaka DrapeADVANCE MEDICAL DESIGNS, INC.JAA2026-06-25
08683161912041GR10XXERA TEKNOLOJI VE YAZILIM LIMITED SIRKETIKPR2026-06-22
08683161912058GR10XXERA TEKNOLOJI VE YAZILIM LIMITED SIRKETIKPR2026-06-22
04056869993973LUMINOS Q.namix RSiemens Healthcare GmbHJAA2025-07-30
04056869993980LUMINOS Q.namix TSiemens Healthcare GmbHJAA2025-07-30
00195278685001OECGE Hualun Medical Systems Co., LtdJAA2025-01-09
00195278913807DefiniumGE Hualun Medical Systems Co., LtdKPR2024-10-30
00195278832252NAGE Hualun Medical Systems Co., LtdKPR2024-07-01
00195278713759NAGE Hualun Medical Systems Co., LtdKPR2023-09-18
00195278713766NAGE Hualun Medical Systems Co., LtdKPR2023-09-18
037013115009403D Imaging Set SPX1ECENTIAL ROBOTICSJAA2023-09-06
037013115009713D Offset Imaging Set SPX1ECENTIAL ROBOTICSJAA2023-09-04
03701311501121SURGIVISIO DEVICEECENTIAL ROBOTICSJAA2023-09-04
08800018420805EXTRON 5DRTECH CorporationJAA2023-08-24
08809413810679ExamVueJPI HEALTHCARE. CO., LTD.KPR2023-06-15
03760172650409APELEMAPELEMJAA2023-06-07
037013115000183D Imaging Set SPX1ECENTIAL ROBOTICSJAA2023-03-01
037013115003913D Offset Imaging Set SPX1ECENTIAL ROBOTICSJAA2023-03-01
03701311500407SURGIVISIOECENTIAL ROBOTICSJAA2023-03-01
04056869951386MULTIX Impact ESiemens Shanghai Medical Equipment Ltd.KPR2022-09-26
00195278485144AlliaGE MEDICAL SYSTEMSJAA2022-04-13
03760172650430APELEMAPELEMJAA2022-04-12