FDA.reportPublic FDA data

PIM Fixed Hand Palm Scanner

Primary DI
08717953004048
Brand
PIM Fixed Hand Palm Scanner
Company
Cablon Medical B.V.
Model
C01-09-02
Catalog number
C01-09-02
Device description
The Patient Identification Module (PIM) is used in radiation therapy clinics to verify the patient's identity prior to treatment by means of a portable sensor, in order to prevent patient mix-ups. An interlock disables the LINAC and treatment will not start so long as the patient is not successfully identified.
Published
2024-11-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe

Contact Domains#

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
K960510000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K960510000THERAVIEWInfimed, Inc.1996-04-22IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08717953004048PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08717953004048087179530040488717953004048

GMDN Terms#

Term, Definition table
TermDefinition
Radiation therapy treatment record/verify systemA dedicated information system comprising computers and software intended to reduce human error by monitoring linear accelerator parameters to verify that the proper radiotherapy treatment is being delivered, and to provide a permanent record. It permits a computer verification of all treatment parameters prior to the commencement of a patient's treatment. Patient information, treatment machine parameters and the dose prescription relating to that patient's treatment are entered into a patient file and stored. Comparisons are made by the record and verify system and system interlocks to ensure that treatment is not permitted if any parameters are outside the predetermined tolerances.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius80 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+31334943964monique.albinus@cablon.nl

Regulatory Flags#

DUNS number
415163591
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08717953004000TheraviewC01-01-00C01-01-002024-11-11
08717953004031TBI Detector 110VC01-05-02C01-05-022024-11-11
08717953004055PIM Portable Hand Palm ScannerC01-09-03C01-09-032024-11-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841962120500Single Hand Extremity FibreplastQfixIYE2026-06-05
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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
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00840510401313KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
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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
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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
08720168162793DSPS-Prominent® Cradle-VIMACROMEDICS B.V.IYE2026-04-22
08720168162854Mask DSPS®-PROSCVRL set/5MACROMEDICS B.V.IYE2026-04-22