FDA.reportPublic FDA data

Sun Nuclear Sono403 Multi-Purpose Phantom SCG

Primary DI
B136403GSLE0
Brand
Sun Nuclear Sono403 Multi-Purpose Phantom SCG
Company
SUN NUCLEAR CORP.
Model
403GSLE
Published
2021-08-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
B136403GSLE0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic ultrasound phantom, test objectA device that consists of a uniform density or a two or three-dimensional (3-D) pattern of objects, materials, or openings of varying dimensions. It includes phantoms that come in both fixed and variable configurations. It is a quality assurance (QA) device that enables both subjective and quantitative evaluations of various calibration and performance characteristics of diagnostic ultrasound systems and associated image acquisition, display, and analysis computer programs.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
122240021
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060608881499RapidCHECKRC10002026-05-10
B136RC10000RapidCheckRC10002018-11-28
05060608882045Daily QA™ 4 Pro10982026-02-24
05060608882052Daily QA™ 4 Pro Wireless10982026-02-24
05060608881574Plan AI10572025-11-07
05060608882038Capintec NEMA IEC NM Body PhantomNMP02732025-11-07
05060608881192SunSILICON10482025-07-08
05060608881208SunSILICON P10492025-07-08
05060608881512Precision Cut GafChromic™ Film15822024-11-01
05060608881178Precision Cut EBT3 GafChromic™ Film1582002024-01-02
05060608880089SRS PROFILER1202500Z1202000-0Z2019-09-17
05060608881123SunSCAN 3D12341234900Z2023-06-08
05060608881130SunSCAN 3D12351235900Z2023-06-08
B136159A0Phototimer Consistency Tools159A2021-12-01
B1361150Sun Nuclear 115A Half Value Layer Attenuator Set115A2021-08-27
B136115H0Sun Nuclear 115H Half Value Layer Attenuator Set115H2021-08-27
B13614640Sun Nuclear Advanced iqModule14642021-08-27
B13614670Sun Nuclear Advanced Electron Density Phantom14672021-08-27
B13614720Sun Nuclear Multi-Energy CT Phantom14722021-08-27
B136159ABR0Sun Nuclear Phototimer Consistency Tools159ABR2021-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812266030932Rando®Providus Holdings, Inc.IXG2024-07-11
00812266030949Rando®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