FDA.reportPublic FDA data

Cios Select

Primary DI
04056869148243
Brand
Cios Select
Company
Siemens Shanghai Medical Equipment Ltd.
Model
11020806
Device description
mobile C-arm; FD
Published
2018-09-20
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
OWBInterventional fluoroscopic x-ray system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OWBInterventional Fluoroscopic X-Ray SystemRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181767000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181767000Cios SelectSiemens Medical Solutions USA, Inc.2018-08-17OWB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04056869148243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04056869148243040568691482434056869148243

GMDN Terms#

Term, Definition table
TermDefinition
Portable general-purpose fluoroscopic x-ray system, digitalA portable (moveable from one location to another, and easily reassembled) general-purpose diagnostic fluoroscopic x-ray system that uses real-time digital techniques for image capture, display and manipulation and is specifically designed to be used in a variety of general-purpose applications requiring real-time fluoroscopic imaging. It includes spot-film capabilities in addition to the fluoroscopic features and is intended to optimize the capability of users to visually and quantitatively evaluate the anatomy and physiological function of various targeted body areas in real-time. It is frequently used in conjunction with an ingested or injected x-ray contrast medium.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)888-7436XX@XX.XX
+1(800)888-7436CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
654129626
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04056869951386MULTIX Impact E11333999113339992022-09-26
04056869279985MULTIX Impact11333888113338882021-04-20
04056869262147MULTIX Impact C11020896110208962021-03-22
04056869010304SOMATOM Emotion 16-slice configuration101659772016-09-24
04056869010311SOMATOM Scope109676662016-09-24
04056869010335Somatom Perspective104955682016-09-24
04056869010342Somatom Perspective SSME108916662016-09-24
04056869295541SOMATOM X.cite115012002025-11-30
04056869295558SOMATOM X.ceed115012012025-11-30
04056869973500SOMATOM Pro.Pulse115947882025-11-30
04056869239736SOMATOM go.Sim110616682020-09-25
04056869239743SOMATOM go.Open Pro110616782020-08-29
04056869051307SOMATOM go.Now110616182017-04-06
04056869051321SOMATOM go.Up110616282017-04-06
04056869151588SOMATOM go.All110616382018-05-26
04056869151595SOMATOM go.Top110616482018-05-26
04056869267180CIOS SELECT115150882023-06-08
04056869267197CIOS SELECT115150552023-06-07
04056869226545MULTIX Impact110207882020-09-23
04056869019888Multix Fusion VA10107466652016-09-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08055186671232A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOWB2026-05-21
08055186671249A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOWB2026-05-21
08055186671256A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOWB2026-05-21
00857088008684TrackXTrackX Technology, LLCOWB2026-05-11
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00841962120548Alpine Stirrups, Metric, LeftQfixOWB2026-04-14
00841962120555Alpine Stirrups, Metric, RightQfixOWB2026-04-14
08809244060533GenorayGENORAY CO., LTD.OWB2026-04-10
08809244060557GenorayGENORAY CO., LTD.OWB2026-04-10
08809244060632GenorayGENORAY CO., LTD.OWB2026-04-10
00850073646120TrackXTrackX Technology, LLCOWB2026-04-08
00850079606043MC2 Portable X-ray SystemOXOS Medical, Inc.OWB2026-03-25
00850079606050EmitterOXOS Medical, Inc.OWB2026-03-25
00850073646106TrackXTrackX Technology, LLCOWB2026-02-24
00198953052488AlliaGE MEDICAL SYSTEMSOWB2025-12-17
00841962120388Lumen AirShuttleQfixOWB2025-12-02
08809244060601GenorayGENORAY CO., LTD.OWB2025-12-01
00850073646045TrackXTrackX Technology, LLCOWB2025-10-24
00850073646052TrackXTrackX Technology, LLCOWB2025-10-24
00850073646069TrackXTrackX Technology, LLCOWB2025-10-24
00850073646076TrackXTrackX Technology, LLCOWB2025-10-24
00850073646083TrackXTrackX Technology, LLCOWB2025-10-24
00850073646113TrackXTrackX Technology, LLCOWB2025-10-15
04056869993973LUMINOS Q.namix RSiemens Healthcare GmbHOWB2025-07-30
04056869993980LUMINOS Q.namix TSiemens Healthcare GmbHOWB2025-07-30
00850073646007TrackXTrackX Technology, LLCOWB2025-07-24
00850073646014TrackXTrackX Technology, LLCOWB2025-07-24