CODONICS INC.

Address:17991 ENGLEWOOD DR.,Cleveland,OH,44130,US

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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

Camera, Multi Format, Radiological (LMC) (8) Gas-Machine, Anesthesia (BSZ) (2)

Premarket Exempt

No Yes

Clear

Codonics Horizon® GS Multi-media Imager - 00814905020106 Catalog Number :

Device Description : Codonics Grayscale Desktop Large Format Film and Paper Diagnostic Imager, 3 Media Input

Device Class : 2

Duns Number: 101533727

Premarket Exempt : No

Product Code : LMC

Prescription Use : Yes

Device Count : 1

Codonics Horizon® SF Multi-media Imager - 00814905020113 Catalog Number :

Device Description : Grayscale/Color Desktop Small Format Film and Paper Diagnostic Imager

Device Class : 2

Duns Number: 101533727

Premarket Exempt : No

Product Code : LMC

Prescription Use : Yes

Device Count : 1

Codonics Horizon® XL Multi-media Imager - 00814905020120 Catalog Number :

Device Description : Grayscale/Color Desktop XL Format Film and Paper Diagnostic Imager

Device Class : 2

Duns Number: 101533727

Premarket Exempt : No

Product Code : LMC

Prescription Use : Yes

Device Count : 1

Codonics SLS500i Operating Software - 00814905020137 Catalog Number :

Device Description : V2.2.0 Operating Software for the Codonics Safe Label System® 500i Point of Care Station

Device Class : 2

Duns Number: 101533727

Premarket Exempt : No

Product Code : BSZ

Prescription Use : Yes

Device Count : 1

Codonics Safe Label System® Administration Tool - 00814905020144 Catalog Number :

Device Description : Administration Tool compatible with Codonics Safe Label System® 500i Point of Care Station

Device Class : 2

Duns Number: 101533727

Premarket Exempt : No

Product Code : BSZ

Prescription Use : Yes

Device Count : 1

Codonics Horizon® Multi-media Imager - 00814905020151 Catalog Number :

Device Description : Grayscale/Color Desktop Large Format Film and Paper Diagnostic Imager - 50C

Device Class : 2

Duns Number: 101533727

Premarket Exempt : No

Product Code : LMC

Prescription Use : Yes

Device Count : 1

Codonics Horizon® Multi-media Imager - 00814905020168 Catalog Number :

Device Description : Grayscale/Color Desktop Small Format Film and Paper Diagnostic Imager - 51C

Device Class : 2

Duns Number: 101533727

Premarket Exempt : No

Product Code : LMC

Prescription Use : Yes

Device Count : 1

Codonics Horizon® Multi-media Imager - 00814905020175 Catalog Number :

Device Description : Grayscale Desktop Large Format Film and Paper Diagnostic Imager - 52C

Device Class : 2

Duns Number: 101533727

Premarket Exempt : No

Product Code : LMC

Prescription Use : Yes

Device Count : 1

Codonics Horizon® Multi-media Imager - 00814905020182 Catalog Number :

Device Description : Grayscale/Color Desktop Large Format Film and Paper Diagnostic Imager -53C

Device Class : 2

Duns Number: 101533727

Premarket Exempt : No

Product Code : LMC

Prescription Use : Yes

Device Count : 1

Codonics Horizon® Multi-media Imager - 00814905020199 Catalog Number :

Device Description : Grayscale/Color Desktop Small Format Film and Paper Diagnostic Imager - 54C

Device Class : 2

Duns Number: 101533727

Premarket Exempt : No

Product Code : LMC

Prescription Use : Yes

Device Count : 1

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