CDR Systems Inc

Address:4334 - 110 Ave SE,Calgary Alberta,CA

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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

Accelerator, Linear, Medical (IYE) (10)

Premarket Exempt

Clear

Sabella Flex - 00628341930253 Catalog Number : SBS14

Device Description : SaBella Flex Dual Axis Precision Positioning Overlay Only

Device Class : 2

Duns Number: 206950904

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Sabella Flex - 00628341930260 Catalog Number : SBS14-K

Device Description : SaBella Flex Dual Axis Precision Positioning Overlay Only (MR Conditional)

Device Class : 2

Duns Number: 206950904

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Prone Breast - 00628341930277 Catalog Number : PB06

Device Description : Prone Breast Positioning

Device Class : 2

Duns Number: 206950904

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Prone Breast - 00628341930284 Catalog Number : PB17

Device Description : Procline

Device Class : 2

Duns Number: 206950904

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Prone Breast - 00628341930291 Catalog Number : PB17-K

Device Description : Procline (MR Conditional)

Device Class : 2

Duns Number: 206950904

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Koilia Mikros - 00628341930307 Catalog Number : BB09-D

Device Description : Koilia Mikros Belly Board

Device Class : 2

Duns Number: 206950904

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

Instaform - 00628341930321 Catalog Number : IFF03

Device Description : Instaform Kit

Device Class :

Duns Number: 206950904

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Freedom - 00628341930338 Catalog Number : SB-HP

Device Description : Freedom Hand Indexer for Linac Couches

Device Class : 2

Duns Number: 206950904

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Freedom - 00628341930345 Catalog Number : PH08

Device Description : Freedom Prone Head & Neck Immobilization

Device Class : 2

Duns Number: 206950904

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Freedom - 00628341930352 Catalog Number : PLUS

Device Description : PLUS Intuition Adapter Plate

Device Class : 2

Duns Number: 206950904

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

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