FDA.reportPublic FDA data

KLARITY MEDICAL

Primary DI
00840510401665
Brand
KLARITY MEDICAL
Company
Klarity Medical Products, LLC
Model
R616-AE5-SP
Device description
Klarity Uno™ Prone Indexing Bar, insert-lock style, fiberglass, 5mm thickness, for R616-series Uno™ Prone Cushion Set indexing on Uno™ Baseplate
Published
2026-10-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
false
Single use
false

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
00840510401665PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840510401665008405104016658405104016650840510401665

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00840510401429KLARITY MEDICALR7527-62C2026-07-08
00840510401238KLARITY MEDICALR7627-20C2026-05-07
00840510400514KLARITY MEDICALR7526-68C2025-12-08
00817355028067KLARITY MEDICALR7645-27BC2025-07-15
00817355029590KLARITY MEDICALR7525-63C2025-06-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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00850065937045eMotusEMPNIA INC.IYE2026-09-21
00850065937052eMotusEMPNIA INC.IYE2026-09-21
00850065937069eMotusEMPNIA INC.IYE2026-09-21
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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