FDA.reportPublic FDA data

KLARITY MEDICAL

Primary DI
00817355029316
Brand
KLARITY MEDICAL
Company
Klarity Medical Products, LLC
Model
RE-616CF
Device description
Klarity Uno™ Lower Indexing Bar, carbon fiber
Published
2025-11-04
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
00817355029316PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817355029316008173550293168173550293160817355029316

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.

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
00817355025127KLARITY MEDICALRB-ESH3-3210CN2026-10-26
00840510401672KLARITY MEDICALGR7661-A21C2026-10-23
00840510401689KLARITY MEDICALGR7661-A22C2026-10-23
00817355029323KLARITY MEDICALRE-7A2025-07-29
00840510401665KLARITY MEDICALR616-AE5-SP2026-10-21
00840510401627KLARITY MEDICALR550-OA12026-10-05
00840510401634KLARITY MEDICALR550-OA22026-10-05
00817355027527KLARITY MEDICALR7800-VBI2023-11-20
00817355025769KLARITY MEDICALRG460C32022-03-16
00817355025776KLARITY MEDICALRG460CH32022-03-16
00817355025370KLARITY MEDICALRCLG-ESH3-2412CMB2021-07-01
00817355023994KLARITY MEDICALRCLG-ESH3-2412CN2019-05-16
00817355022201Klarity MedicalRLG-ESH3-2412CN2016-12-05
00817355022393Klarity MedicalRLG-ELH-2412CN2017-01-27
00817355022409Klarity MedicalRLG-ELS-2412CN2017-01-27
00817355022447Klarity MedicalRLG-ESH2-2412C2017-03-20
00817355022850Klarity MedicalRLG-ESH1-2412C2017-07-17
00840510401511KLARITY MEDICALR7628-15C2026-08-11
00840510401603KLARITY MEDICALR7529-61C2026-09-18
00840510401450KLARITY MEDICALR7253-10NHC2026-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817355025127KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-26
00840510401672KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-23
00840510401689KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-23
00840510401665KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-21
00840510401658KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-08
00840510401627KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-05
00840510401634KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-05
00840510401641KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-05
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