LODOX SYSTEMS (PTY) LTD

Address:7 DARTFIELD RD., KRAMERVILLE,SANDTON Gauteng,ZA

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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, Tomography, Computed (JAK) (1)

Premarket Exempt

Clear

LODOX - 06009880828166 Catalog Number : CL-08-0013-H2

Device Description : The Xmplar-dr is a full body, low dose, X-ray scanner which produce digital X-ra The Xmplar-dr is a full body, low dose, X-ray scanner which produce digital X-ray images used for diagnostic purposes in both trauma and general radiology cases as well as in forensic pathology cases.

Device Class : 2

Duns Number: 635684694

Premarket Exempt : No

Product Code : JAK

Prescription Use : Yes

Device Count : 1

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