SPECTRUM DYNAMICS MEDICAL, INC

Address:301 N. Cattlemen Rd. Suite 109,Sarasota,FL,34232,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, Tomography, Computed, Emission (KPS) (10) System, Image Processing, Radiological (LLZ) (7)

Premarket Exempt

Clear

D-SPECT® - 07290108670004 Catalog Number : 8010029-01

Device Description : Single-photon emission computed tomography system

Device Class : 2

Duns Number: 078864620

Premarket Exempt : No

Product Code : LLZ, KPS

Prescription Use : Yes

Device Count : 1

D-SPECT® - 07290108670011 Catalog Number : 8010029-01

Device Description : Single-photon emission computed tomography system

Device Class : 2

Duns Number: 078864620

Premarket Exempt : No

Product Code : KPS, LLZ

Prescription Use : Yes

Device Count : 1

D-SPECT® - 07290108670028 Catalog Number : 8010018-01

Device Description : Single-photon emission computed tomography system

Device Class : 2

Duns Number: 078864620

Premarket Exempt : No

Product Code : LLZ, KPS

Prescription Use : Yes

Device Count : 1

D-SPECT® - 07290108670035 Catalog Number : 8010018-01

Device Description : Single-photon emission computed tomography system

Device Class : 2

Duns Number: 078864620

Premarket Exempt : No

Product Code : LLZ, KPS

Prescription Use : Yes

Device Count : 1

D-SPECT® L - 07290108670042 Catalog Number : 8010020-01

Device Description : Single-photon emission computed tomography system

Device Class : 2

Duns Number: 078864620

Premarket Exempt : No

Product Code : KPS, LLZ

Prescription Use : Yes

Device Count : 1

D-SPECT® L - 07290108670059 Catalog Number : 8010032-01

Device Description : Single-photon emission computed tomography system

Device Class : 2

Duns Number: 078864620

Premarket Exempt : No

Product Code : LLZ, KPS

Prescription Use : Yes

Device Count : 1

D-SPECT® Cardio - 07290108670066 Catalog Number : 8010120-01

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

Device Class : 2

Duns Number: 078864620

Premarket Exempt : No

Product Code : KPS

Prescription Use : Yes

Device Count : 1

D-SPECT® Cardio - 07290108670073 Catalog Number : 8010121-01

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 ® processing and Reviewing Workstation - 07290108670080 Catalog Number : 8010113-01

Device Description : Single Photon Emission Computed Tomography system, stand alone processing station.

Device Class : 2

Duns Number: 078864620

Premarket Exempt : No

Product Code : LLZ, KPS

Prescription Use : Yes

Device Count : 1

VERITON NM - 07290108670103 Catalog Number : 8010184-01

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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