FDA.reportPublic FDA data

Diaphragm Control

Primary DI
09120074391192
Brand
Diaphragm Control
Company
IT-V Medizintechnik GmbH
Model
P10107-119
Published
2021-10-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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
K081218000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081218000BELLYSTEP, HEADSTEP, BREASTSTEP, PROSTEP, WINGSTEP AND ICASTIt-V Medizintechnik, GmbH2008-07-21IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09120074391192PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09120074391192091200743911929120074391192

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
300005408
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09120074394063HS Indexing AdapterP10107-4062016-09-01
09120074394339HS Indexing Adapter Elekta 530P10107-4332016-09-01
09120074397040System HeadSTEP MR glasfibreP10107-7042016-09-01
09120074394001HeadSTEP MR Basic ModuleP10107-4002016-09-01
09120074395176HS S-TYPE Basic Module MRP10107-5172018-04-16
09120074397194System HS S-TYPE MRP10107-7192018-04-16
09120074394490HS Bite Angulating Fixation Set WideP10107-4492016-09-01
09120074397910System HeadSTEP Bite WideP10107-7912016-09-01
09120074396364Wall holder for CT STEPP10107-6362016-09-01
09120074394018HeadSTEP IMRT MR Basic ModuleP10107-4012024-11-12
09120074395312WingSTEP high for Varian BaseplateP10107-5312024-11-12
09120074395329WingSTEP low for Varian BaseplateP10107-5322024-11-12
09120074395404BreastSTEP Short Mask Basic ModuleP10107-5402024-11-12
09120074395411BreastSTEP Long Mask Basic ModuleP10107-5412024-11-12
09120074395428BreastSTEP Short MR Basic ModuleP10107-4372024-11-12
09120074395435BreastSTEP Long MR Basic ModuleP10107-5432024-11-12
09120074391000HeadSTEP Carbon Basic ModuleP10107-1002016-09-01
09120074391017HeadSTEP Carbon Flat Basic ModuleP10107-1012016-09-01
09120074391604BellySTEP BaseplateP10107-1602016-09-01
09120074394025HeadSTEP iBEAM evo Extension Basic ModuleP10107-4022016-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840510401368KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-09
00840510401351KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-08
00841962120500Single Hand Extremity FibreplastQfixIYE2026-06-05
00841962120517Knee / Elbow Extremity FibreplastQfixIYE2026-06-05
00841962120524Foot Extremity FibreplastQfixIYE2026-06-05
00841962120531Dual Hand / Shoulder Extremity FibreplastQfixIYE2026-06-05
00841439115305MultiFix 2QfixIYE2026-06-04
00841439115312MultiFix 2 - JointGlowQfixIYE2026-06-04
00841439115329Extremity RiserQfixIYE2026-06-04
00841439115336Extremity Riser - JointGlowQfixIYE2026-06-04
00841439115343MultiFix Indexing PostQfixIYE2026-06-04
00840510401320KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-03
00840510401344KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-03
00840510401283KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401290KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401306KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401313KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401337KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401276KLARITY MEDICALKlarity Medical Products, LLCIYE2026-05-29
08057014731224LIAC HWLS.I.T. SORDINA IORT TECHNOLOGIES SPAIYE2026-04-30
08057014731231LIAC HWLS.I.T. SORDINA IORT TECHNOLOGIES SPAIYE2026-04-30
08720168162595Mask DSPS®-PROSH set/5MACROMEDICS B.V.IYE2026-04-23
08720168162564DSPS-Prominent® Cradle-IIMACROMEDICS B.V.IYE2026-04-22
08720168162571Mask DSPS®-PROSHVRL set/5MACROMEDICS B.V.IYE2026-04-22
08720168162618Mask DSPS®-PROSHL set/5MACROMEDICS B.V.IYE2026-04-22
08720168162649Mask DSPS®-PROSHVR set/5MACROMEDICS B.V.IYE2026-04-22
08720168162748Mask DSPS®-PROH, set/5MACROMEDICS B.V.IYE2026-04-22
08720168162755Mask DSPS®-PRO, set/5MACROMEDICS B.V.IYE2026-04-22
08720168162779DSPS-Prominent® Cradle-IIIMACROMEDICS B.V.IYE2026-04-22
08720168162786DSPS-Prominent® Cradle-IVMACROMEDICS B.V.IYE2026-04-22