FDA.reportPublic FDA data

SIUI

Primary DI
06938396410049
Brand
SIUI
Company
Shantou Institute of Ultrasonic Instruments Co., Ltd.
Model
SR-1000
Device description
Portable DR Imaging System
Published
2021-01-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
IZLSystem, X-Ray, Mobile
LLZSystem, Image Processing, Radiological
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IZLSystem, X-Ray, MobileRadiology2
LLZSystem, Image Processing, RadiologicalRadiology2
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)Radiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202350000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202350000SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)2021-01-06IZL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06938396410049PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06938396410049069383964100496938396410049

GMDN Terms#

Term, Definition table
TermDefinition
Portable basic diagnostic x-ray system, digitalAn assembly of devices that comprise a general-purpose portable diagnostic x-ray system used in a variety of routine planar x-ray imaging applications. It uses digital techniques for image capture, display and manipulation. The portable design allows it to operate on either mains or battery power and to be easily disassembled, moved from location to another, and easily reassembled for use. It consists of modular configurations that can be upgraded by the addition of hardware/software components. This GMDN code does not cover systems with fluoroscopic or tomographic capabilities.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
654090299
Device count
1
Combination product
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06938396493028SIUIV6L11C2025-12-05
06938396400347SIUIL14LC2025-07-21
06938396400484SIUIReadius C52025-07-21
06938396400491SIUIC32025-07-21
06938396400552SIUIC62025-07-21
06938396400569SIUIL82025-07-21
06938396400965SIUIReadius L152025-07-21
06938396400972SIUIReadius L102025-07-21
06938396400989SIUIReadius L82025-07-21
06938396400996SIUIReadius L52025-07-21
06938396401016SIUIReadius P82025-07-21
06938396401023SIUIReadius P52025-07-21
06938396401030SIUIReadius P32025-07-21
06938396401047SIUIReadius V62025-07-21
06938396401054SIUIReadius V52025-07-21
06938396401061SIUIReadius C62025-07-21
06938396401078SIUIReadius C32025-07-21
06938396401283SIUIC6LF2025-07-21
06938396402754SIUIP32025-07-21
06938396401337SIUIApogee C12025-07-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00628184004500Intellijoint VIEWIntellijoint Surgical IncLLZ2026-06-09
00860005144082Brain AgeDeephealth, Inc.LLZ2026-06-08
07649997938038Swissmeda Dental Planning SystemSwissmeda AGLLZ2026-06-08
07649997938052Swissmeda Dental Planning SystemSwissmeda AGLLZ2026-06-08
00850025268417Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LLZ2026-06-05
00850631008865Roentgen WorksBrit Systems, LLCLLZ2026-06-05
08437021468212QP-ProstateQUIBIM SOCIEDAD LIMITADA.LLZ2026-06-05
08057737122040Villa Sistemi MedicaliVILLA SISTEMI MEDICALI SPAMQB2026-06-04
08057737122057Villa Sistemi MedicaliVILLA SISTEMI MEDICALI SPAMQB2026-06-04
B359OAIIV2026051RamsoftRamsoft IncLLZ2026-06-04
M722CD26127V260970ClearRead CT DockerRiverain Technologies, Inc.LLZ2026-05-28
17540262200096Change Healthcare Stratus Imaging Diagnostic ViewerChange Healthcare Canada CompanyLLZ2026-05-27
75401622522101Synthesis Vision ViewerSynthesis Health Intelligence IncLLZ2026-05-27
08800011150129DRGEMDRGEM CorporationMQB2026-05-20
08800011150129DRGEMDRGEM CorporationIZL2026-05-20
08800011150136DRGEMDRGEM CorporationIZL2026-05-20
08800011150136DRGEMDRGEM CorporationMQB2026-05-20
08437021722093ADAS 3DADAS3D MEDICAL S.L.LLZ2026-05-12
08033837938835no brandCEFLA SOCIETA' COOPERATIVALLZ2026-05-11
08437021468045QP-Brain®QUIBIM SOCIEDAD LIMITADA.LLZ2026-05-06
08437023642016NemoCastSOFTWARE NEMOTEC SLLLZ2026-04-23
08437023642023NemoFABSOFTWARE NEMOTEC SLLLZ2026-04-23
EOLENEUROINSIGHTV1P00Neuro InsightOlea Medical USALLZ2026-04-13
EOLENEUROVASIV1P00Neurovascular InsightOlea Medical USALLZ2026-04-13
08056304455864Caas QardiaPie Medical Imaging B.V.LLZ2026-04-03
08055186671089A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLMQB2026-04-02
08800011150112DRGEMDRGEM CorporationMQB2025-08-26
08437021468175QP-ProstateQUIBIM SOCIEDAD LIMITADA.LLZ2025-07-04
09421904268333Volpara ScorecardLUNIT INTERNATIONAL LIMITEDLLZ2025-05-06
088000186022562430TCARayence Co., Ltd.LLZ2025-04-08