FDA.reportPublic FDA data

Catalyst+

Primary DI
17350005280762
Brand
Catalyst+
Company
C-Rad Positioning AB
Model
SP003-0001
Published
2024-08-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K200435000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200435000Catalyst+, Catalyst+ HDC-Rad Positioning AB2020-05-07IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17350005280762PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1735000528076217350005280762

GMDN Terms#

Term, Definition table
TermDefinition
Laser patient positioning systemA fixed or variable focal distance lasing device assembly designed to project a harmless beam (light pattern) onto a patient's skin or other alignment device. It is typically used to position and/or monitor the position of a patient during diagnostic imaging, radiation therapy, or radiation therapy treatment planning or simulation procedures. A set of these assemblies is used to enable precise and reproducible 1, 2, or multi-dimensional alignment of a selected portion(s) of the patient's anatomy with respect to a radiation beam(s) used during diagnostic or therapeutic procedures. It typically includes a light source, mechanical/electronic controls, and associated mounting devices.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+15617429260support@c-rad.com

Regulatory Flags#

DUNS number
509296997
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17350005280779Catalyst+ HDSP003-00022024-08-06
17350005280786Catalyst+ HD Ring GantrySP003-00072024-08-06
17350005280793Catalyst+ PTSP003-00082024-08-06
17350005280809Catalyst+ PT X4SP003-00092024-08-06
07350005280017Sentinel SP0012016-09-22
17350005280038Catalyst+SP003HY-0042020-07-16
17350005280045Catalyst+SP003HY-0052020-07-16
17350005280052HIT LaserHITSDX red2020-07-16
17350005280069HIT laserHITSDX Green2020-07-16
17350005280076HIT LaserHITSDXY Red2020-07-16
17350005280083HIT LaserHITSDXY green2020-07-16
17350005280090HIT LaserHITMX Red&Green2020-07-16
17350005280106HIT LaserHITMX Red2020-07-16
17350005280113HIT LaserHITMX Green2020-07-16
17350005280120HIT LaserHITMXY Red&Green2020-07-16
17350005280137HIT LaserHITMXY Red2020-07-16
17350005280144HIT LaserHITMXY Green2020-07-16
17350005280151HIT LaserHIT Red&Green2020-07-16
17350005280168HIT LaserHIT Red2020-07-16
17350005280175HIT LaserHIT Green2020-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850065937045eMotusEMPNIA INC.IYE2026-09-21
00850065937052eMotusEMPNIA INC.IYE2026-09-21
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00850065937076eMotusEMPNIA INC.IYE2026-09-21
00850065937083eMotusEMPNIA INC.IYE2026-09-21
00850065937090eMotusEMPNIA INC.IYE2026-09-21
00850065937106eMotusEMPNIA INC.IYE2026-09-21
00850065937113eMotusEMPNIA INC.IYE2026-09-21
00850065937120eMotusEMPNIA INC.IYE2026-09-21
00850065937137eMotusEMPNIA INC.IYE2026-09-21
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00850065937151eMotusEMPNIA INC.IYE2026-09-21
00850065937168eMotusEMPNIA INC.IYE2026-09-21
00850065937175eMotusEMPNIA INC.IYE2026-09-21
00850065937182eMotusEMPNIA INC.IYE2026-09-21
00850065937199eMotusEMPNIA INC.IYE2026-09-21
00850065937205eMotusEMPNIA INC.IYE2026-09-21
00850065937212eMotusEMPNIA INC.IYE2026-09-21
00850065937229eMotusEMPNIA INC.IYE2026-09-21
00850065937236eMotusEMPNIA INC.IYE2026-09-21
00850065937243eMotusEMPNIA INC.IYE2026-09-21
00850065937250eMotusEMPNIA INC.IYE2026-09-21
00850065937267eMotusEMPNIA INC.IYE2026-09-21
00850065937274eMotusEMPNIA INC.IYE2026-09-21
00850065937298eMotusEMPNIA INC.IYE2026-09-21
00850065937304eMotusEMPNIA INC.IYE2026-09-21