FDA.reportPublic FDA data

MUCheck®

Primary DI
00860175002403
Brand
MUCheck®
Company
Oncology Data Systems Inc
Model
MUCheck®
Device description
MUCheck® Independent Dose Calculation Software. MUCheck® Software. MUCheck® Software Suite. Oncology Data Systems, Inc.
Published
2021-04-30
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
LHNSystem, Radiation Therapy, Charged-Particle, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2
LHNSystem, Radiation Therapy, Charged-Particle, MedicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K980904000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K980904000MUCHECK MONITOR UNIT VALIDATION PROGRAMMedical Dosimetry Services, Inc.1998-06-08IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860175002403PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860175002403008601750024038601750024030860175002403

GMDN Terms#

Term, Definition table
TermDefinition
Radiation therapy softwareAn application software program intended to facilitate/support the delivery of therapeutic radiation by enabling computer-assisted functionality in one or more of the following areas: treatment planning, simulation, record/verify, beam block CAD/CAM, quality assurance, and patient positioning. Some types may be combined with specific hardware or firmware accessories or configurations in order to function as intended.

Contacts#

Phone, Email table
PhoneEmail
4056805222management@mucheck.com

Regulatory Flags#

DUNS number
044931900
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850065937007eMotusEMPNIA INC.LHN2026-09-21
00850065937007eMotusEMPNIA INC.IYE2026-09-21
00850065937014eMotusEMPNIA INC.IYE2026-09-21
00850065937014eMotusEMPNIA INC.LHN2026-09-21
00850065937021eMotusEMPNIA INC.LHN2026-09-21
00850065937021eMotusEMPNIA INC.IYE2026-09-21
00850065937038eMotusEMPNIA INC.LHN2026-09-21
00850065937038eMotusEMPNIA INC.IYE2026-09-21
00850065937045eMotusEMPNIA INC.LHN2026-09-21
00850065937045eMotusEMPNIA INC.IYE2026-09-21
00850065937052eMotusEMPNIA INC.LHN2026-09-21
00850065937052eMotusEMPNIA INC.IYE2026-09-21
00850065937069eMotusEMPNIA INC.IYE2026-09-21
00850065937069eMotusEMPNIA INC.LHN2026-09-21
00850065937076eMotusEMPNIA INC.LHN2026-09-21
00850065937076eMotusEMPNIA INC.IYE2026-09-21
00850065937083eMotusEMPNIA INC.IYE2026-09-21
00850065937083eMotusEMPNIA INC.LHN2026-09-21
00850065937090eMotusEMPNIA INC.IYE2026-09-21
00850065937090eMotusEMPNIA INC.LHN2026-09-21
00850065937106eMotusEMPNIA INC.IYE2026-09-21
00850065937106eMotusEMPNIA INC.LHN2026-09-21
00850065937113eMotusEMPNIA INC.LHN2026-09-21
00850065937113eMotusEMPNIA INC.IYE2026-09-21
00850065937120eMotusEMPNIA INC.IYE2026-09-21
00850065937120eMotusEMPNIA INC.LHN2026-09-21
00850065937137eMotusEMPNIA INC.IYE2026-09-21
00850065937137eMotusEMPNIA INC.LHN2026-09-21
00850065937144eMotusEMPNIA INC.IYE2026-09-21
00850065937144eMotusEMPNIA INC.LHN2026-09-21