FDA.reportPublic FDA data

OmniBoard™ BTM, S-Type

Primary DI
08719425707600
Brand
OmniBoard™ BTM, S-Type
Company
MACROMEDICS B.V.
Model
UATB-BTMS
Catalog number
175010
Device description
OmniBoard Breast Treatment Module for S-Type
Published
2017-03-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
K142420000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142420000Patient Positioning DevicesMacromedics BV2015-03-27IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08719425707600PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08719425707600087194257076008719425707600

GMDN Terms#

Term, Definition table
TermDefinition
Indexed-immobilization patient positioning systemA assembly of devices used primarily in radiation therapy applications, and consisting of an indexed treatment or imaging table (couch) that contains locking interfaces used to attach various positioning and immobilization devices to numbered or lettered (indexing) points on the table. It is used to ensure both adequate positioning and immobilization of a patient and to help ensure reproducible alignment between a target portion of the patient's anatomy and the radiation beams or fields used in radiation therapy treatments, diagnostic imaging studies. It may accommodate a variety of anatomically targeted patient positioning and immobilization attachments.

Regulatory Flags#

DUNS number
489730120
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08720168162595Mask DSPS®-PROSH set/51139102026-04-23
08720168162564DSPS-Prominent® Cradle-II1131502026-04-22
08720168162571Mask DSPS®-PROSHVRL set/51138902026-04-22
08720168162618Mask DSPS®-PROSHL set/51139202026-04-22
08720168162649Mask DSPS®-PROSHVR set/51139402026-04-22
08720168162748Mask DSPS®-PROH, set/51139302026-04-22
08720168162755Mask DSPS®-PRO, set/51139902026-04-22
08720168162779DSPS-Prominent® Cradle-III1131602026-04-22
08720168162786DSPS-Prominent® Cradle-IV1131702026-04-22
08720168162793DSPS-Prominent® Cradle-VI1131802026-04-22
08720168162854Mask DSPS®-PROSCVRL set/51137602026-04-22
08720168162861Mask DSPS®-PROSC set/51137702026-04-22
08720168162878Mask DSPS®-PROSCVR set/51137802026-04-22
08720168162885Mask DSPS®-PROSCL set/51137902026-04-22
08720168163325DSPS-Prominent® Cradle-VII1132602026-04-22
08720168163356DSPS-Prominent® SH profile set/21130902026-04-22
08720168163387DSPS PRO Mask Shim Set HNS1132502026-04-22
08720168163394DSPS PRO Mask Shim Set HO1132702026-04-22
08720168160140DSPS-Prominent® baseplate 1131202026-04-21
08720168162557DSPS-Prominent® Cradle-I1131402026-04-21

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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