FDA.reportPublic FDA data

External Right

Primary DI
B525FI09C0
Brand
External Right
Company
Octostop Inc
Model
FI-09C
Published
2017-11-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KPRSystem, x-ray, stationary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPRSystem, X-Ray, StationaryRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K952871000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K952871000RIDGES PLUSOctostop, Inc.1995-07-20KPR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B525FI09C0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
X-ray/radiation therapy beam filter, wedgeA wedge-shaped metal filter placed in a beam of primary radiation before it reaches the patient undergoing radiation therapy or imaging procedure. In radiation therapy it ensures uniform irradiation of body areas that vary in thickness or density. In diagnostic imaging it is used to obtain films of a more uniform density when the part being examined diminishes greatly in thickness from one side of the field to the other. It is typically made from aluminium (Al), lead (Pb), copper (Cu), tin (Sn) or combinations of these. Also called compensation filter because when one side of a patient is considerably thicker/denser than the other, the wedge compensates for the physical difference.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
240536946
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
B525BO020Standard BoardBO-022017-11-16
B525BO030Large BoardBO-032017-11-16
B525CO010Large U Head CushionsCO-012017-11-16
B525CO020Small U Head CushionsCO-022017-11-16
B525CO030L Head and Arm CushionsCO-032017-11-16
B525OC010OctogonesOC-012017-11-16
B525OC020Vertical SupportOC-022017-11-16
B525PA030Octopaque no AccessoriesPA-032017-11-16
B525PA040MinipaquePA-042017-11-16
B525PA050Universal OctopaquePA-052017-11-16
B525PA060Universal Octopaque with Vertical SupportPA-062017-11-16
B525PA070Universal Octopaque (Large Board)PA-072017-11-16
B525ST070Large Flanel BlanketST-072017-11-16
B525ST080Small Flanel BlanketST-082017-11-16
B525ST090Velcro Strap for OctopaqueST-092017-11-16
B525ST100Self-Adhesive VelcroST-102017-11-16
B525ST130Large Flanel Blanket (Package of 6)ST-132017-11-16
B525ST140Small Flanel Blanket (Package of 6)ST-142017-11-16
B525ST160XL Flanel BlanketST-162017-11-16
B525ST170Flanel Blanket Small (3) Large (3)ST-172017-11-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08908021109004PRORAD 3NCPROGNOSYS MEDICAL SYSTEMS PRIVATE LIMITEDKPR2026-05-07
08908021109011PRORAD 2FCPROGNOSYS MEDICAL SYSTEMS PRIVATE LIMITEDKPR2026-05-07
08809365280001SG HealthcareSG Healthcare Co., Ltd.KPR2026-04-24
08809365281015SG HealthcareSG Healthcare Co., Ltd.KPR2026-04-24
00198953056103DefiniumGE Hualun Medical Systems Co., LtdKPR2026-02-12
00198953056158DefiniumGE Hualun Medical Systems Co., LtdKPR2026-02-12
04056869297309MOBILETT ImpactSiemens Healthcare GmbHKPR2025-11-20
00195278913807DefiniumGE Hualun Medical Systems Co., LtdKPR2024-10-30
00195278840226DiscoveryGE Hualun Medical Systems Co., LtdKPR2024-07-04
04540217071319RADspeed ProSHIMADZU CORPORATIONKPR2024-04-01
04540217071326RADspeed ProSHIMADZU CORPORATIONKPR2024-04-01
00195278526892DefiniumGE Hualun Medical Systems Co., LtdKPR2023-09-18
00884838110588Precision CRFPhilips Medical Systems DMC GmbHKPR2023-02-14
B216DRH700AC1X-CEL X-RAY CORPORATIONARQUILLA, INC.KPR2022-12-20
04056869951386MULTIX Impact ESiemens Shanghai Medical Equipment Ltd.KPR2022-09-26
00884838103221ProxiDiagnost N90Philips Medical Systems DMC GmbHKPR2022-01-17
04056869279985MULTIX ImpactSiemens Shanghai Medical Equipment Ltd.KPR2021-04-20
04056869262147MULTIX Impact CSiemens Shanghai Medical Equipment Ltd.KPR2021-03-22
08436046003026SEDECALSEDECALKPR2021-02-15
08436046003033SEDECALSEDECALKPR2021-02-15
00195278070265DefiniumGE Hualun Medical Systems Co., LtdKPR2020-11-24
00810035220386Radmedix AcuityFDRRADMEDIX, LLCKPR2020-09-18
00810035220393Radmedix AcuityFDR+RADMEDIX, LLCKPR2020-09-18
00810035220409Radmedix AcuityCDRRADMEDIX, LLCKPR2020-09-18
00810035220416Radmedix AcuitySDRRADMEDIX, LLCKPR2020-09-18
00810035220423Radmedix AcuitySDR+RADMEDIX, LLCKPR2020-09-18
00810030350071uDRUIH TECHNOLOGIES LLCKPR2020-05-26
00810030350002uDRUIH TECHNOLOGIES LLCKPR2020-04-29
08800011121235FDR ClinicaDRGEM CorporationKPR2019-11-20
08800011121242FDR ClinicaDRGEM CorporationKPR2019-11-20