FDA.reportPublic FDA data

BodyFIX

Primary DI
04056719000332
Brand
BodyFIX
Company
3C-Medical Intelligence GmbH
Model
P10102-413
Catalog number
P10102-413
Device description
BodyFIX® Indexing Adapter P2 is used for attaching the BodyFIX base plate to indexed tabletops provided by other manufacturers. This is required for using the BodyFIX System on other tabletops. The delivery set of the BodyFIX® Indexing Adapter P2 contains three indexing adapters.
Published
2016-08-23
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
K121530000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121530000BODYFIX SYSTEMMedical Intelligence Medizintechnik GmbH2012-06-20IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04056719000332PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04056719000332040567190003324056719000332

GMDN Terms#

Term, Definition table
TermDefinition
Vacuum-mould patient positioning systemAn assembly of devices designed to apply a vacuum to a cushion or bag filled with foam-like material that is placed under, on, or around a patients body parts. A vacuum is applied to the contents of the cushion forming a patient specific (custom-made) mould. The moulds can be whole body or selected body parts and help ensure adequate positioning and immobilization of the patient during diagnostic imaging and/or radiation therapy procedures facilitating reproducible positioning for serial procedures. This system typically includes reusable foam-filled bags, cushions, a vacuum unit, hardware, seals, and interfaces used to connect the mould to another patient positioning system (PPS).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
314546664
Device count
1
Lot or batch
true
Manufacturing date on label
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
04056719002039iGUIDEP10603-111P10603-1112017-10-13
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

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