ECOTRON

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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

Image-Intensified Fluoroscopic X-Ray System, Mobile (OXO) (3) Interventional Fluoroscopic X-Ray System (OWB) (3) System, X-Ray, Fluoroscopic, Image-Intensified (JAA) (3) Generator, High-Voltage, X-Ray, Diagnostic (IZO) (2) Unit, X-Ray, Extraoral With Timer (EHD) (1)

Premarket Exempt

No Yes

Clear

N/A - 08800019200154 Catalog Number : ECO-ER-CAT-001S

Device Description : LINE POWER RATING: 400V3~, 50/60HzOUTPUT RATING: 68kW(800mA@85kV, 640mA@106kV, 4 LINE POWER RATING: 400V3~, 50/60HzOUTPUT RATING: 68kW(800mA@85kV, 640mA@106kV, 400mA@150kV) KVP range: 40~150kVpmA range: 10~800mAmAs Range: 0.1~500mAs

Device Class : 1

Duns Number: 688209954

Premarket Exempt : Yes

Product Code : IZO

Prescription Use : No

Device Count : 1

N/A - 08800019200161 Catalog Number : ECO-ER-CAT-001S

Device Description : LINE POWER RATING: 400V3~, 50/60HzOUTPUT RATING: 82kW(1000mA@82kV, 800mA@102kV, LINE POWER RATING: 400V3~, 50/60HzOUTPUT RATING: 82kW(1000mA@82kV, 800mA@102kV, 500mA@150kV) KVP range: 40~150kVpmA range: 10~1000mAmAs Range: 0.1~500mAs

Device Class : 1

Duns Number: 688209954

Premarket Exempt : Yes

Product Code : IZO

Prescription Use : No

Device Count : 1

NA - 08800019200253 Catalog Number : ECO-ER-CAT-001DR

Device Description : 1. Line Voltage: 220~230V, 50/60Hz2. Output Power: 2.4kW3. Fluoroscopy Mode - F 1. Line Voltage: 220~230V, 50/60Hz2. Output Power: 2.4kW3. Fluoroscopy Mode - F-mode: 0.5~10mA - P-mode: 0.5~20mA - Boost mode: 30mA - DS mode: 10~30mA4. Radiography Mode - kV range: 40~110kV, mA range: 16~30mA, mAs range: 0.8~100mAs5. X-ray Tube - XRR-2551(Rotating Type), Focal Spot: 0.3/0.6, Target Angle: 10degree, Anode Heat Storage: 210kHU6. Detector - VIVIX-D 1212G (VIEWORKS), 12 x 12 inch

Device Class : 2

Duns Number: 688209954

Premarket Exempt : No

Product Code : OXO, JAA, OWB

Prescription Use : No

Device Count : 1

NA - 08800019200260 Catalog Number : ECO-ER-CAT-001DR

Device Description : 1. Line Voltage: 220~230V, 50/60Hz2. Output Power: 3.2kW3. Fluoroscopy Mode - F 1. Line Voltage: 220~230V, 50/60Hz2. Output Power: 3.2kW3. Fluoroscopy Mode - F-mode: 0.5~10mA - P-mode: 0.5~20mA - Boost mode: 30mA - DS mode: 10~30mA4. Radiography Mode - kV range: 40~110kV, mA range: 15~40mA, mAs range: 0.8~100mAs5. X-ray Tube - XRR-2551(Rotating Type), Focal Spot: 0.3/0.6, Target Angle: 10degree, Anode Heat Storage: 210kHU6. Detector - VIVIX-D 1212G (VIEWORKS), 12 x 12 inch

Device Class : 2

Duns Number: 688209954

Premarket Exempt : No

Product Code : OWB, JAA, OXO

Prescription Use : No

Device Count : 1

NA - 08800019200277 Catalog Number : ECO-ER-CAT-001DR

Device Description : 1. Line Voltage: 220~230V, 50/60Hz2. Output Power: 5.0kW3. Fluoroscopy Mode - F 1. Line Voltage: 220~230V, 50/60Hz2. Output Power: 5.0kW3. Fluoroscopy Mode - F-mode: 0.5~10mA - P-mode: 0.5~20mA - Boost mode: 30mA - DS mode: 10~30mA4. Radiography Mode - kV range: 40~125kV, mA range: 20~100mA, mAs range: 0.8~200mAs5. X-ray Tube - XRR-2551(Rotating Type), Focal Spot: 0.3/0.6, Target Angle: 10degree, Anode Heat Storage: 210kHU6. Detector - VIVIX-D 1212G (VIEWORKS), 12 x 12 inch

Device Class : 2

Duns Number: 688209954

Premarket Exempt : No

Product Code : OXO, JAA, OWB

Prescription Use : No

Device Count : 1

N/A - 08800019200406 Catalog Number : ECO-ER-CAT-001DT

Device Description : - Extraoral source x-ray systemBattery Input: 22.2V, 1AOutput Rating: 210WkVp: 7 - Extraoral source x-ray systemBattery Input: 22.2V, 1AOutput Rating: 210WkVp: 70kVmA: 3mASec: 0.02 - 0.5sec

Device Class : 2

Duns Number: 688209954

Premarket Exempt : No

Product Code : EHD

Prescription Use : No

Device Count : 1

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