Shanghai United Imaging Healthcare Co., Ltd.

Address:No.2258 Chengbei Rd. Jiading District,Shanghai,CN

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Image Processing, Radiological (LLZ) (5) Automated Radiological Image Processing Software (QIH) (1)

Premarket Exempt

Clear

uWS - 06971576834013 Catalog Number :

Device Description : MR Image Post-Processing Software

Device Class : 2

Duns Number: 421271328

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

uWS - 06971576834020 Catalog Number :

Device Description : CT Image Post-Processing Software

Device Class : 2

Duns Number: 421271328

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

uWS - 06971576834037 Catalog Number :

Device Description : PET/CT Image Post-Processing Software

Device Class : 2

Duns Number: 421271328

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

uWS - 06971576834143 Catalog Number :

Device Class : 2

Duns Number: 421271328

Premarket Exempt : No

Product Code : LLZ, QIH

Prescription Use : Yes

Device Count : 1

uWS - 06971576834150 Catalog Number :

Device Class : 2

Duns Number: 421271328

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

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