FDA.reportPublic FDA data

SIUI

Primary DI
06938396401658
Brand
SIUI
Company
Shantou Institute of Ultrasonic Instruments Co., Ltd.
Model
SR-2000
Device description
Portable DR Imaging System
Published
2026-07-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

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
K253058000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253058000Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd.2026-06-18IZL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06938396401658PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06938396401658069383964016586938396401658

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.

Regulatory Flags#

DUNS number
654090299
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
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
06938396401528SIUISR-1002026-07-10
06938396401559SIUISR-100Pro2026-07-10
06938396401566SIUISR-2002026-07-10
06938396401597SIUISR-200Pro2026-07-10
06938396401603SIUISR-3002026-07-10
06938396401634SIUISR-300Pro2026-07-10
06938396401702SIUISR-1000Pro2026-07-10
06938396401719SIUISR-1100Pro2026-07-10
06938396410124SIUISR-2300Pro2026-07-10
06938396440008SIUICTS-40002026-07-10
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05420060351228TruMatch CMF Titanium 3D Printed SplintsMaterialise NVLLZ2026-10-20
TKRL0001F1540PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F1B80PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F34K0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F6000PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F7300PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F7940PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F7F80PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F9F00PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001FF640PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001FLI00PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001KF5I0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001L0LD0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001L4120PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001L7FI0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001L9260PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000200F30PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000201K20PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000202L80PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000203ID0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000205I00PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0002066I0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000207330PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000208K50PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0002098I0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000209F30PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL00020D0F0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL00020F080PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL00020F670PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL00020I510PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20