RT-125 Rough Terrain Mobile X-Ray Unit
FDA 510(k) K894643 · Lorad Medical Systems, Inc.
510(k) numberK894643
Submission
- Device name
- RT-125 Rough Terrain Mobile X-Ray Unit
- Applicant
- Lorad Medical Systems, Inc.
Danbury, CT, US - Received
- July 24, 1989
- Decision date
- December 14, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was RT-125 Rough Terrain Mobile X-Ray Unit cleared by the FDA?
RT-125 Rough Terrain Mobile X-Ray Unit (K894643) received a 510(k) decision of Substantially Equivalent on December 14, 1989, 143 days after the submission was received.
What is the product code of K894643?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.