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

System, X-Ray, Mobile (IZL) (6) Generator, High-Voltage, X-Ray, Diagnostic (IZO) (3) Image-Intensified Fluoroscopic X-Ray System, Mobile (OXO) (1) Interventional Fluoroscopic X-Ray System (OWB) (1) System, X-Ray, Fluoroscopic, Image-Intensified (JAA) (1)

Premarket Exempt

No Yes

Clear

NA - 08800019200000 Catalog Number : ECO-ER-CAT-001P

Device Description : Input Power: 110V~120V, 50/60HzOutput Power: 1.6kWKVP range: 40~90kVmA range: 12 Input Power: 110V~120V, 50/60HzOutput Power: 1.6kWKVP range: 40~90kVmA range: 12~30mAmAs range: 0.4~32mAsX-ray Tube: D-125Focal Sport: 1.2 x 1.2mmTarget Angle: 16 degreesAnode heat storage: 50kHU

Device Class : 2

Duns Number: 688209954

Premarket Exempt : No

Product Code : IZL

Prescription Use : No

Device Count : 1

NA - 08800019200017 Catalog Number : ECO-ER-CAT-001P

Device Description : Input Power: 110V~120V, 50/60HzOutput Power: 2.4kWKVP range: 40~100kVmA range: 1 Input Power: 110V~120V, 50/60HzOutput Power: 2.4kWKVP range: 40~100kVmA range: 16~40mAmAs range: 0.4~100mAsX-ray Tube: D-125Focal Sport: 1.2 x 1.2mmTarget Angle: 16 degreesAnode heat storage: 50kHU

Device Class : 2

Duns Number: 688209954

Premarket Exempt : No

Product Code : IZL

Prescription Use : No

Device Count : 1

NA - 08800019200024 Catalog Number : ECO-ER-CAT-001P

Device Description : Input Power: 110V~120V, 50/60HzOutput Power: 2.8kWKVP range: 40~120kVmA range: 1 Input Power: 110V~120V, 50/60HzOutput Power: 2.8kWKVP range: 40~120kVmA range: 14~40mAmAs range: 0.4~100mAsX-ray Tube: D-125Focal Sport: 1.2 x 1.2mmTarget Angle: 16 degreesAnode heat storage: 50kHU

Device Class : 2

Duns Number: 688209954

Premarket Exempt : No

Product Code : IZL

Prescription Use : No

Device Count : 1

NA - 08800019200031 Catalog Number : ECO-ER-CAT-001P

Device Description : Input Power: 200V~240V, 50/60HzOutput Power: 3.2kWKVP range: 40~100kVmA range: 2 Input Power: 200V~240V, 50/60HzOutput Power: 3.2kWKVP range: 40~100kVmA range: 25~60mAmAs range: 0.4~100mAsX-ray Tube: D-205BFocal Sport: 2.0 x 2.0mmTarget Angle: 20 degreesAnode heat storage: 40kHU

Device Class : 2

Duns Number: 688209954

Premarket Exempt : No

Product Code : IZL

Prescription Use : No

Device Count : 1

NA - 08800019200048 Catalog Number : ECO-ER-CAT-001P

Device Description : Input Power: 200V~240V, 50/60HzOutput Power: 4.0kWKVP range: 50~110kVmA range: 2 Input Power: 200V~240V, 50/60HzOutput Power: 4.0kWKVP range: 50~110kVmA range: 20~80mAmAs range: 0.4~100mAsX-ray Tube: OX/110-15Focal Sport: 1.8 x 1.8mmTarget Angle: 15 degreesAnode heat storage: 42kHU

Device Class : 2

Duns Number: 688209954

Premarket Exempt : No

Product Code : IZL

Prescription Use : No

Device Count : 1

NA - 08800019200055 Catalog Number : ECO-ER-CAT-001P

Device Description : Input Power: 200V~240V, 50/60HzOutput Power: 5.0kWKVP range: 50~110kVmA range: 2 Input Power: 200V~240V, 50/60HzOutput Power: 5.0kWKVP range: 50~110kVmA range: 20~100mAmAs range: 0.4~100mAsX-ray Tube: OX/110-15Focal Sport: 1.8 x 1.8mmTarget Angle: 15 degreesAnode heat storage: 42kHU

Device Class : 2

Duns Number: 688209954

Premarket Exempt : No

Product Code : IZL

Prescription Use : No

Device Count : 1

NA - 08800019200093 Catalog Number : ECO-ER-CAT-002C

Device Description : 1. Line Voltage: 220~230V, 50/60Hz2. Output Power: 5kW3. Fluoroscopy Mode - F-m 1. Line Voltage: 220~230V, 50/60Hz2. Output Power: 5kW3. 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. Image Intensifier - E5830SD-PA4(TOSHIBA), 9inch7. Camera - CCD, Resolution: 1K X 1K

Device Class : 2

Duns Number: 688209954

Premarket Exempt : No

Product Code : OWB, JAA, OXO

Prescription Use : No

Device Count : 1

N/A - 08800019200123 Catalog Number : ECO-ER-CAT-001S

Device Description : LINE POWER RATING: 230V, 50/60HzOUTPUT RATING: 32kW(400mA@80kV, 320mA@100kV, 250 LINE POWER RATING: 230V, 50/60HzOUTPUT RATING: 32kW(400mA@80kV, 320mA@100kV, 250mA@125kV) KVP range: 40~125kVpmA range: 10~400mAmAs Range: 0.1~400mAs

Device Class : 1

Duns Number: 688209954

Premarket Exempt : Yes

Product Code : IZO

Prescription Use : No

Device Count : 1

N/A - 08800019200130 Catalog Number : ECO-ER-CAT-001S

Device Description : LINE POWER RATING: 230V, 50/60HzOUTPUT RATING: 40kW(500mA@80kV, 400mA@100kV, 320 LINE POWER RATING: 230V, 50/60HzOUTPUT RATING: 40kW(500mA@80kV, 400mA@100kV, 320mA@125kV) KVP range: 40~125kVpmA range: 10~500mAmAs Range: 0.1~500mAs

Device Class : 1

Duns Number: 688209954

Premarket Exempt : Yes

Product Code : IZO

Prescription Use : No

Device Count : 1

N/A - 08800019200147 Catalog Number : ECO-ER-CAT-001S

Device Description : LINE POWER RATING: 400V3~, 50/60HzOUTPUT RATING: 52kW(640mA@81kV, 400mA@130kV, 3 LINE POWER RATING: 400V3~, 50/60HzOUTPUT RATING: 52kW(640mA@81kV, 400mA@130kV, 320mA@150kV) KVP range: 40~150kVpmA range: 10~640mAmAs Range: 0.1~500mAs

Device Class : 1

Duns Number: 688209954

Premarket Exempt : Yes

Product Code : IZO

Prescription Use : No

Device Count : 1

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