SYNOPSYS, INC.

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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) (10)

Premarket Exempt

Clear

Simpleware ScanIP - 00863520000307 Catalog Number :

Device Class : 2

Duns Number: 161499579

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

Simpleware ScanIP - 00863520000314 Catalog Number :

Device Class : 2

Duns Number: 161499579

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

Simpleware ScanIP - 00863520000321 Catalog Number :

Device Class : 2

Duns Number: 161499579

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

Synopsys Simpleware ScanIP - 00863520000338 Catalog Number :

Device Class : 2

Duns Number: 161499579

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

Synopsys Simpleware ScanIP - 00863520000345 Catalog Number :

Device Class : 2

Duns Number: 161499579

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

Synopsys Simpleware ScanIP - 00863520000352 Catalog Number :

Device Class : 2

Duns Number: 161499579

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

Synopsys Simpleware ScanIP - 00863520000369 Catalog Number :

Device Class : 2

Duns Number: 161499579

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

Simpleware ScanIP Medical - 00863520000376 Catalog Number :

Device Class : 2

Duns Number: 161499579

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

Simpleware ScanIP Medical - 00863520000383 Catalog Number :

Device Class : 2

Duns Number: 161499579

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

Simpleware ScanIP Medical - 00863520000390 Catalog Number :

Device Description : Current software release: S-2021.06Simpleware ScanIP Medical is intended for use Current software release: S-2021.06Simpleware ScanIP Medical is intended for use as a software interface and image segmentation system for the transfer of medical imaging information to an output file. It is also intended as pre-operative software for diagnostic and surgical planning.For these purposes, output files can also be used for the fabrication of physical replicas using traditional or additive manufacturing methods. The physical replicas can be used for diagnostic purposes in the field of orthopedic, maxillofacial and cardiovascular applications.The software is intended to be used in conjunction with other diagnostic tools and expert clinical judgment.

Device Class : 2

Duns Number: 161499579

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

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