SPECTRUM DYNAMICS MEDICAL, INC

Address:301 N. Cattlemen Rd. Suite 109,Sarasota,FL,34232,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

System, Tomography, Computed, Emission (KPS) (5) System, X-Ray, Tomography, Computed (JAK) (2)

Premarket Exempt

Clear

VERITON CT - 07290108670110 Catalog Number : 8010142-01

Device Description : Single Photon Emission Computed Tomography System combined with a Computed Tomog Single Photon Emission Computed Tomography System combined with a Computed Tomography (CT) system for x-ray imaging,

Device Class : 2

Duns Number: 078864620

Premarket Exempt : No

Product Code : JAK, KPS

Prescription Use : Yes

Device Count : 1

VERITON CT - 07290108670127 Catalog Number : 8010172-01

Device Class : 2

Duns Number: 078864620

Premarket Exempt : No

Product Code : KPS, JAK

Prescription Use : Yes

Device Count : 1

D-SPECT VISTA - 07290108670134 Catalog Number : 8010266-01

Device Description : Single Photon Emission Computed Tomography System, 110 V

Device Class : 2

Duns Number: 078864620

Premarket Exempt : No

Product Code : KPS

Prescription Use : Yes

Device Count : 1

D-SPECT VISTA - 07290108670141 Catalog Number : 8010267-01

Device Description : Single Photon Emission Computed Tomography System, 230V

Device Class : 2

Duns Number: 078864620

Premarket Exempt : No

Product Code : KPS

Prescription Use : Yes

Device Count : 1

D-SPECT Refurbished - 07290108670158 Catalog Number : 8010013-01

Device Description : Single Photon Emission Computed Tomography system

Device Class : 2

Duns Number: 078864620

Premarket Exempt : No

Product Code : KPS

Prescription Use : Yes

Device Count : 1

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