FDA.reportPublic FDA data

iGUIDE

Primary DI
04056719002039
Brand
iGUIDE
Company
3C-Medical Intelligence GmbH
Model
P10603-111
Catalog number
P10603-111
Device description
iGUIDE Software 2.2.2 is the software which controls the movement of the the HexaPOD™ evo Module and monitors the correct position of the module
Published
2017-10-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
IYEAccelerator, Linear, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143485000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143485000iGuide 2.1Medical Intelligence Medizintechnik GmbH2015-03-04IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04056719002039PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04056719002039040567190020394056719002039

GMDN Terms#

Term, Definition table
TermDefinition
Accelerator system table, poweredAn electrically-powered and/or programmable radiotherapy device that is a component of an accelerator system specifically designed to position and support a patient, typically supine, during treatments administered using a medical linear accelerator or non-linear accelerator. It is a flat surface on legs that includes electronic and/or software controls for top height adjustments and positioning. It may be an independent device that is stationary or mobile, or it can be an integral component of a medical accelerator system design.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
314546664
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04056719002268iGUIDEP10603-111-224P10603-1112026-04-22
04056719002190iGUIDEP10603-111-223P10603-1112019-08-01
04056719001704iGUIDEP10603-109P10603-1092016-08-23
04056719001742iGUIDEP10603-110P10603-1102017-02-24
04056719001728BodyFIXP10102-305 P10102-305 2016-08-23
04056719001735BodyFIXP10102-309P10102-3092016-08-23
04056719001773FraxionP10106-322 P10106-322 2016-08-23
04056719001780FraxionP10106-323 P10106-323 2016-08-23
04056719001803HeadFIXP10103-309 P10103-309 2016-08-23
04056719001810HeadFIXP10103-311 P10103-311 2016-08-23
04056719001827HeadFIXP10103-312 P10103-312 2016-08-23
04056719001834HeadFIXP10103-403 P10103-403 2016-08-23
04056719001858HeadFIXP10103-603 P10103-603 2016-08-23
04056719001865HeadFIXP10103-604 P10103-604 2016-08-23
04056719002220iBEAM®P10105-1822020-06-18
04056719002251iBEAMP10105-184P10105-1842022-07-12
04056719002244HexaPODP10603-300P10603-3002021-09-28
04056719002213iBEAM®P10105-3002020-08-20
04056719002237iBEAM®P10105-1832020-07-07
04056719000011BodyFIXP10102-101 P10102-101 2016-08-23

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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