FDA.reportPublic FDA data

Raypilot Table Displacement Meter

Primary DI
07350007954077
Brand
Raypilot Table Displacement Meter
Company
Micropos Medical AB (Publ)
Model
1
Catalog number
4007
Device description
Raypilot Table Displacement Meter is aimed to assist any movement of treatment table to match laser.
Published
2023-04-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
K203722000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203722000RayPilot SystemMicropos Medical AB2021-09-02IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350007954077PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350007954077073500079540777350007954077

GMDN Terms#

Term, Definition table
TermDefinition
Radiation therapy invasive marker lesion localization systemAn assembly of noninvasive devices intended to monitor the position of a patient's tumour/lesion relative to the isocenter of a radiation therapy system, to assist with their alignment during treatment planning or a therapeutic procedure. It localizes the position of invasive markers [e.g., electromagnetic (EM) signal transmitters, radiopaque markers] (not included) which have been introduced/implanted in or near the target site prior to treatment. It typically includes an EM receiver and dedicated software.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure00
Handling Environment Humidity00
Handling Environment Temperature00
Storage Environment Atmospheric Pressure00
Storage Environment Humidity00
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+46317608005info@micropos.se

Regulatory Flags#

DUNS number
350533316
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350007952202Raypilot Receiver120202025-03-12
07350007956026Raypilot System Cable160022025-03-12
07350007951045Raypilot Hypocath110042023-04-04
07350007951052Raypilot Viewcath110052023-04-04
07350007952219Raypilot Extension Plate120212023-04-04
07350007953049Raypilot Software130042023-04-04
07350007954053Raypilot Quality Control Kit140052023-04-04
07350007954060Raypilot Transmitter Tester140062023-04-04
07350007956019Raypilot Transmitter Cable160012023-04-04
07350007956033Raypilot Power Box160032023-04-04
07350007956040Raypilot Matching Network160042023-04-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840510401412KLARITY MEDICALKlarity Medical Products, LLCIYE2026-07-08
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00840510401405KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-23
00840510401375KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-22
00840510401368KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-09
00840510401351KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-08
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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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00840510401337KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401276KLARITY MEDICALKlarity Medical Products, LLCIYE2026-05-29
08057014731224LIAC HWLS.I.T. SORDINA IORT TECHNOLOGIES SPAIYE2026-04-30
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