EDDA TECHNOLOGY, INC.

Address:5 Independence Way,Princeton,NJ,08540,US

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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) (3) System, X-Ray, Tomography, Computed (JAK) (1)

Premarket Exempt

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EDDA TECHNOLOGY - 00868466000206 Catalog Number :

Device Description : IQQA-Chest is an image analysis CAD software used during the review of digital c IQQA-Chest is an image analysis CAD software used during the review of digital chest radiographic images.

Device Class : 2

Duns Number: 782779701

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

EDDA TECHNOLOGY - 00868466000213 Catalog Number :

Device Description : IQQA-Liver is an image analysis software for reviewing multiphase images derived IQQA-Liver is an image analysis software for reviewing multiphase images derived from CT and MR scanners

Device Class : 2

Duns Number: 782779701

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

EDDA TECHNOLOGY - 00868466000220 Catalog Number :

Device Description : IQQA-BodyImaging is an image analysis software for reviewing body imaging studie IQQA-BodyImaging is an image analysis software for reviewing body imaging studies (including thoracic, abdominal and pelvic) derived from CT and MR scanners

Device Class : 2

Duns Number: 782779701

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

EDDA TECHNOLOGY - 00868466000237 Catalog Number :

Device Description : IQQA-Guide is intended for intra-operative guidance for surgical procedures

Device Class : 2

Duns Number: 782779701

Premarket Exempt : No

Product Code : JAK

Prescription Use : Yes

Device Count : 1

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