Del Medical, Inc.

Address:241 Covington Dr,Bloomingdale,IL,60108,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

Table, Radiographic, Non-Tilting, Powered (IZZ) (4) Solid State X-Ray Imager (Flat Panel/Digital Imager) (MQB) (1) System, X-Ray, Mobile (IZL) (1) Holder, Radiographic Cassette, Wall-Mounted (IXY) (1) Table, Radiologic (KXJ) (1) Tube Mount, X-Ray, Diagnostic (IYB) (1) System, X-Ray, Stationary (KPR) (1)

Premarket Exempt

No Yes

Clear

Del Medical - 00858340006004 Catalog Number :

Device Description : This a motorized mobile diagnostic x-ray system. The Mobile Direct Radiographic This a motorized mobile diagnostic x-ray system. The Mobile Direct Radiographic system facilitates x-ray examinations, in situations where it is not feasible to transport the patient to a ward with fixed equipment. The unit is precise, yet easy to maneuver due to smooth battery-powered motorization

Device Class : 2

Duns Number: 078671236

Premarket Exempt : No

Product Code : IZL

Prescription Use : No

Device Count : 1

Del Medical/Universal - 00858340006011 Catalog Number :

Device Description : The EV650 elevating table is designed for general purpose radiography and featur The EV650 elevating table is designed for general purpose radiography and features a four-way floating table top with longitudinal and transverse travel. It uses electromechanical locks to maintain the desired position. It has a motor-driven telescopic base that can raise and lower the table top. It has a patient weight limit of 650 lbs.

Device Class : 2

Duns Number: 078671236

Premarket Exempt : Yes

Product Code : IZZ

Prescription Use : No

Device Count : 1

Del Medical/Universal - 00858340006028 Catalog Number :

Device Description : The EV800 elevating table is designed for general purpose radiography and featur The EV800 elevating table is designed for general purpose radiography and features a four-way floating table top with longitudinal and transverse travel. It uses electromechanical locks to maintain the desired position. It has a motor-driven telescopic base that can raise and lower the table top. It has a patient weight limit of 800 lbs.

Device Class : 2

Duns Number: 078671236

Premarket Exempt : Yes

Product Code : IZZ

Prescription Use : No

Device Count : 1

Del Medical/Universal - 00858340006035 Catalog Number :

Device Description : The RT100 float-top table is designed for general purpose radiography and featur The RT100 float-top table is designed for general purpose radiography and features a four-way floating table top with longitudinal and transverse travel. It uses electromechanical locks to maintain the desired position. It has a patient weight limit of 700 lbs.

Device Class : 2

Duns Number: 078671236

Premarket Exempt : Yes

Product Code : IZZ

Prescription Use : No

Device Count : 1

DMX System - 00858340006073 Catalog Number :

Device Description : The DM-FWFC is the version of the DMX x-ray system that utilizes the floor to wa The DM-FWFC is the version of the DMX x-ray system that utilizes the floor to wall floor to ceiling tube mount (FWFC).

Device Class : 2

Duns Number: 078671236

Premarket Exempt : No

Product Code : KPR

Prescription Use : No

Device Count : 1

DelWorks - 00858340006097 Catalog Number :

Device Description : PORTABLE WORKSTATIONWirelessly Transfer Images Directly to PACS, Ultra-light, an PORTABLE WORKSTATIONWirelessly Transfer Images Directly to PACS, Ultra-light, and Portable, Design tested to handle, water, dust, and splash resistanceThe DELWORKS FIT portable tablet workstation aims to maximize the portability and efficiency of the DELWORKS software - utilizing it anytime, anywhere.

Device Class : 2

Duns Number: 078671236

Premarket Exempt : No

Product Code : MQB

Prescription Use : No

Device Count : 1

Del Medical/Universal - 00858340006103 Catalog Number :

Device Description : The MT500 mobile radiographic table is designed for general purpose radiography The MT500 mobile radiographic table is designed for general purpose radiography and features a table top and rolling base. It has a patient weight limit of 500 lbs.

Device Class : 2

Duns Number: 078671236

Premarket Exempt : Yes

Product Code : KXJ

Prescription Use : No

Device Count : 1

Del Medical/Universal - 00858340006110 Catalog Number :

Device Description : An x-ray system component intended to be mounted to the ceiling, to support and An x-ray system component intended to be mounted to the ceiling, to support and facilitate position of the x-ray tube. The OTC18S allows for synchronized tracking and stitching.

Device Class : 1

Duns Number: 078671236

Premarket Exempt : Yes

Product Code : IYB

Prescription Use : No

Device Count : 1

Straight Arm - 00858340006127 Catalog Number :

Device Description : The Straight Arm is an economical and space-efficient X-ray system that can perf The Straight Arm is an economical and space-efficient X-ray system that can perform a comprehensive range of radiographic procedures.Its flexibility permits imaging of patients sitting or standing, as well as recumbent when optional mobile table is present

Device Class : 1

Duns Number: 078671236

Premarket Exempt : Yes

Product Code : IXY

Prescription Use : No

Device Count : 1

Del Medical/Universal - 00858340006134 Catalog Number :

Device Description : The EV800T elevating table is designed for general purpose radiography and featu The EV800T elevating table is designed for general purpose radiography and features a four-way floating table top with longitudinal and transverse travel. The EV800T is intended to be used with the DM-OTC18S auto-stitching system.

Device Class : 2

Duns Number: 078671236

Premarket Exempt : Yes

Product Code : IZZ

Prescription Use : No

Device Count : 1

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