SOURCE-RAY, INC.

Address:50 Fleetwood Ct,Ronkonkoma,NY,11779,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

Assembly, Tube Housing, X-Ray, Diagnostic (ITY) (5) System, X-Ray, Mobile (IZL) (5)

Premarket Exempt

No Yes

Clear

UC-5000 - 00867538000304 Catalog Number : 900117

Device Description : Mobile X-Ray System for General Purpose Radiography Exams Utilizing Film, Comput Mobile X-Ray System for General Purpose Radiography Exams Utilizing Film, Computed Radiography, or Direct Digital Flat Panels

Device Class : 2

Duns Number: 113928654

Premarket Exempt : No

Product Code : IZL

Prescription Use : Yes

Device Count : 1

XRS-140-15K-P - 00867538000311 Catalog Number : 900051

Device Description : X-ray Source Assembly, 140V, 15 mA- Pulsed

Device Class : 1

Duns Number: 113928654

Premarket Exempt : Yes

Product Code : ITY

Prescription Use : No

Device Count : 1

XRS-140-7.5K-P - 00867538000328 Catalog Number : 900145

Device Description : X-Ray Source Assembly, 140V, 7.5mA, Pulsed

Device Class : 1

Duns Number: 113928654

Premarket Exempt : Yes

Product Code : ITY

Prescription Use : No

Device Count : 1

SB-60-333 - 00868162000203 Catalog Number : 900046

Device Description : SourceBlock Assembly, 60kVp / 333uA

Device Class : 1

Duns Number: 113928654

Premarket Exempt : Yes

Product Code : ITY

Prescription Use : No

Device Count : 1

XRS-125-7K-P - 00868162000210 Catalog Number : 900043

Device Description : X-Ray Source Assembly, 125kVp, 7ma / Pulsed

Device Class : 1

Duns Number: 113928654

Premarket Exempt : Yes

Product Code : ITY

Prescription Use : No

Device Count : 1

SB-80-200R - 00868162000227 Catalog Number : 900086

Device Description : SourceBlock Assembly, 80kVp / 200uA

Device Class : 1

Duns Number: 113928654

Premarket Exempt : Yes

Product Code : ITY

Prescription Use : No

Device Count : 1

SR-115-CG - 00868162000234 Catalog Number : 900033

Device Description : X-Ray Control / Generator, 100 kVp/ 15mA

Device Class : 2

Duns Number: 113928654

Premarket Exempt : No

Product Code : IZL

Prescription Use : Yes

Device Count : 1

SR-130-G - 00868162000241 Catalog Number : 910056

Device Description : X-Ray Generator / Tube Housing Assembly, 100kVp / 30mA

Device Class : 2

Duns Number: 113928654

Premarket Exempt : No

Product Code : IZL

Prescription Use : Yes

Device Count : 1

SR-130-C - 00868162000258 Catalog Number : 910002

Device Description : X-Ray Control, 100kVp / 30 mA

Device Class : 2

Duns Number: 113928654

Premarket Exempt : No

Product Code : IZL

Prescription Use : Yes

Device Count : 1

SR-1260-C - 00868162000265 Catalog Number : 910224

Device Description : X-Ray Control, 120 kVp / 60mA

Device Class : 2

Duns Number: 113928654

Premarket Exempt : No

Product Code : IZL

Prescription Use : Yes

Device Count : 1

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