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) System, Therapeutic, X-Ray (JAD) (2)

Premarket Exempt

Clear

Freedom - 00628341930055 Catalog Number : LB-SBRT-1

Device Description : Freedom Comprehensive CT/Treatment Overlay

Device Class : 2

Duns Number: 206950904

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Freedom - 00628341930062 Catalog Number : LB-SBRT-1-K

Device Description : Freedom Comprehensive CT/Treatment Overlay (MR Conditional)

Device Class :

Duns Number: 206950904

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Freedom - 00628341930079 Catalog Number : LB02

Device Description : Freedom Basic CT/Treatment Overlay

Device Class :

Duns Number: 206950904

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Freedom - 00628341930086 Catalog Number : LB02-K

Device Description : Freedom Basic CT/Treatment Overlay (MR Conditional)

Device Class :

Duns Number: 206950904

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Freedom - 00628341930093 Catalog Number : LB-SBRT-X

Device Description : Freedom Comprehensive CT/Treatment Overlay Gen-X

Device Class :

Duns Number: 206950904

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Freedom - 00628341930109 Catalog Number : LB-SBRT-X-K

Device Description : Freedom Comprehensive CT/Treatment Overlay Gen-X (MR Conditional)

Device Class :

Duns Number: 206950904

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Bolus - Gel (film) - 00628341930116 Catalog Number : g-Bolus-A

Device Description : Gel Bolus (with film)

Device Class :

Duns Number: 206950904

Premarket Exempt : No

Product Code : JAD, IYE

Prescription Use : Yes

Device Count : 1

Bolus - Gel (w/o Film) - 00628341930123 Catalog Number : g-Bolus-B

Device Description : Gel Bolus (without film)

Device Class :

Duns Number: 206950904

Premarket Exempt : No

Product Code : JAD, IYE

Prescription Use : Yes

Device Count : 1

Positioning Aids - 00628341930130 Catalog Number :

Device Description : Wedges, supports and positioning aids

Device Class :

Duns Number: 206950904

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Index Bar - 00628341930147 Catalog Number : IB06

Device Description : Index Bar

Device Class : 2

Duns Number: 206950904

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

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