FDA.reportPublic FDA data

SIUI

Primary DI
06938396400125
Brand
SIUI
Company
Shantou Institute of Ultrasonic Instruments Co., Ltd.
Model
Apogee 1T
Device description
Digital Color Doppler Ultrasound Imaging System
Published
2021-09-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYNSystem, Imaging, Pulsed Doppler, UltrasonicRadiology2
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210317000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210317000Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee 1U/ Apogee 1T/ Apogee 1G Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)2021-08-19IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06938396400125PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06938396400125069383964001256938396400125

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
654090299
Device count
1
Kit
true
Serial number
true

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
06938396401658SIUISR-20002026-07-10
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

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Primary DI, Brand, Company table
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