FDA.reportPublic FDA data

KLARITY MEDICAL

Primary DI
00840510400088
Brand
KLARITY MEDICAL
Company
Klarity Medical Products, LLC
Model
R625-NFCF9
Device description
Klarity CT Overlay for Toshiba Alexion
Published
2026-03-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

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
K112460000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112460000MULTIPLELarson Medical Products, Inc.2011-10-07IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840510400088PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840510400088008405104000888405104000880840510400088

GMDN Terms#

Term, Definition table
TermDefinition
Indexed-immobilization patient positioning systemA assembly of devices used primarily in radiation therapy applications, and consisting of an indexed treatment or imaging table (couch) that contains locking interfaces used to attach various positioning and immobilization devices to numbered or lettered (indexing) points on the table. It is used to ensure both adequate positioning and immobilization of a patient and to help ensure reproducible alignment between a target portion of the patient's anatomy and the radiation beams or fields used in radiation therapy treatments, diagnostic imaging studies. It may accommodate a variety of anatomically targeted patient positioning and immobilization attachments.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
034824691
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840510401603KLARITY MEDICALR7529-61C2026-09-18
00840510401559KLARITY MEDICALR624-AIRCF012026-08-25
00840510401450KLARITY MEDICALR7253-10NHC2026-08-03
00840510401443KLARITY MEDICALR7201-06C2026-07-24
00840510401436KLARITY MEDICALR550-L32026-07-22
00840510401412KLARITY MEDICALR7703-85NHC2026-07-08
00840510401429KLARITY MEDICALR7527-62C2026-07-08
00840510401382KLARITY MEDICALR7509-80C2026-06-23
00840510401399KLARITY MEDICALR7530-25C2026-06-23
00840510401405KLARITY MEDICALR7540-56C2026-06-23
00840510401375KLARITY MEDICALR7524-120BBC2026-06-22
00840510401368KLARITY MEDICALRKB-3010VT2026-06-09
00840510401351KLARITY MEDICALR610-ND2-1CF2026-06-08
00840510401276KLARITY MEDICALR550-LBS2026-05-29
00840510400392KLARITY MEDICALR550-LB42025-10-28
00840510401320KLARITY MEDICALGR7103S1-A01.5C2026-06-03
00840510401344KLARITY MEDICALGR7103S2-A02C2026-06-03
00840510401283KLARITY MEDICALR616-HT22026-06-01
00840510401290KLARITY MEDICALR624-SCF1-62026-06-01
00840510401306KLARITY MEDICALR624-SCF1-82026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850065937250eMotusEMPNIA INC.IYE2026-09-21
00850065937267eMotusEMPNIA INC.IYE2026-09-21
00850065937274eMotusEMPNIA INC.IYE2026-09-21
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00850065937304eMotusEMPNIA INC.IYE2026-09-21