FDA.reportPublic FDA data

Rando®

Primary DI
00812266030949
Brand
Rando®
Company
Providus Holdings, Inc.
Model
XA235R
Catalog number
XA235R
Device description
Elbow 90° flexion, right
Published
2024-07-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IXGPhantom, Anthropomorphic, Radiographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IXGPhantom, Anthropomorphic, RadiographicRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812266030949PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812266030949008122660309498122660309490812266030949

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose diagnostic x-ray phantom, anthropomorphicA device that consists of preserved human or animal tissue, or a two or three-dimensional (3-D) tissue-equivalent model designed to mimic the functional, physical, or a combination of these characteristics of a normal or diseased human organ or organ systems. It is a quality assurance (QA) device intended to permit both subjective and quantitative evaluation of the overall function of both conventional and digital general-purpose x-ray systems and associated image acquisition, display and analysis computer programs. The design can incorporate fluid pumps and moveable components. This GMDN code includes biopsy and other kinds of interventional procedure training phantoms.

Regulatory Flags#

DUNS number
104162493
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812266031403Catphan®CTP764CTP7642025-01-13
00812266030529Corgi®CGI014CGI0142024-10-03
00812266030932Rando®XA235LXA235L2024-07-11
00812266030956Rando®XA231PXA231P2024-07-11
00812266030963Rando®XA231RXA231R2024-07-11
00812266030970Rando®XA245LXA245L2024-07-11
00812266030987Rando®XA245RXA245R2024-07-11
00812266030994Rando®XA241LXA241L2024-07-11
00812266031007Rando®XA241RXA241R2024-07-11
00812266030758LiquiPhil™TLP226TLP2262024-05-07
00812266030765LiquiPhil™TLP280TLP2802024-05-07
00812266030772LiquiPhil™TLP260TLP2602024-05-07
00812266030789LiquiPhil™TLP269TLP2692024-05-07
00812266030796LiquiPhil™DDP010DDP0102024-05-07
00812266030802LiquiPhil™DDP015DDP0152024-05-07
00812266030697LiquiPhil™TLP133TLP1332024-05-03
00812266030703LiquiPhil™TLP134TLP1342024-05-03
00812266030710LiquiPhil™TLP250TLP2502024-05-03
00812266030727LiquiPhil™TLP290TLP2902024-05-03
00812266030734LiquiPhil™TLP211TLP2112024-05-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812266030932Rando®Providus Holdings, Inc.IXG2024-07-11
00812266030956Rando®Providus Holdings, Inc.IXG2024-07-11
00812266030963Rando®Providus Holdings, Inc.IXG2024-07-11
00812266030970Rando®Providus Holdings, Inc.IXG2024-07-11
00812266030987Rando®Providus Holdings, Inc.IXG2024-07-11
00812266030994Rando®Providus Holdings, Inc.IXG2024-07-11
00812266031007Rando®Providus Holdings, Inc.IXG2024-07-11
06977071930908MeicenGuangdong Meicen Medical Equipment Co., Ltd.IXG2024-06-21
00812266030758LiquiPhil™Providus Holdings, Inc.IXG2024-05-07
00812266030765LiquiPhil™Providus Holdings, Inc.IXG2024-05-07
00812266030772LiquiPhil™Providus Holdings, Inc.IXG2024-05-07
00812266030789LiquiPhil™Providus Holdings, Inc.IXG2024-05-07
00812266030796LiquiPhil™Providus Holdings, Inc.IXG2024-05-07
00812266030802LiquiPhil™Providus Holdings, Inc.IXG2024-05-07
00812266030697LiquiPhil™Providus Holdings, Inc.IXG2024-05-03
00812266030703LiquiPhil™Providus Holdings, Inc.IXG2024-05-03
00812266030710LiquiPhil™Providus Holdings, Inc.IXG2024-05-03
00812266030727LiquiPhil™Providus Holdings, Inc.IXG2024-05-03
00812266030734LiquiPhil™Providus Holdings, Inc.IXG2024-05-03
00812266030741LiquiPhil™Providus Holdings, Inc.IXG2024-05-03
09355529000033T1CMR Phantom (1.5T)RESONANCE HEALTH ANALYSIS SERVICES PTY LTDIXG2024-04-17
09355529000064T1CMR Phantom (3.0T)RESONANCE HEALTH ANALYSIS SERVICES PTY LTDIXG2024-04-17
09355529000071T2CMR PhantomRESONANCE HEALTH ANALYSIS SERVICES PTY LTDIXG2024-04-17
09355529000088R2*/T2* PhantomRESONANCE HEALTH ANALYSIS SERVICES PTY LTDIXG2024-04-17
00812266030673LiquiPhil™Providus Holdings, Inc.IXG2024-03-18
00812266030680LiquiPhil™Providus Holdings, Inc.IXG2024-03-18
EIBASR020010myQA® SRS Phantom CyberknifeIBA Dosimetry GmbHIXG2023-10-10
00850019946505Standard Imaging Lucy 3D QA PhantomSTANDARD IMAGING INC.IXG2023-06-22
00850019946512Standard Imaging MIMI PhantomSTANDARD IMAGING INC.IXG2023-06-22
00850019946529Standard Imaging Stereotactic Dose Verification PhantomSTANDARD IMAGING INC.IXG2023-06-22