MDR17 Mobile Direct Radiographic System
FDA 510(k) K173018 · Del Medical, Inc.
510(k) numberK173018
Submission
- Device name
- MDR17 Mobile Direct Radiographic System
- Applicant
- Del Medical, Inc.
Bloomingdale, IL, US - Received
- September 28, 2017
- Decision date
- November 20, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was MDR17 Mobile Direct Radiographic System cleared by the FDA?
MDR17 Mobile Direct Radiographic System (K173018) received a 510(k) decision of Substantially Equivalent on November 20, 2017, 53 days after the submission was received.
What is the product code of K173018?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.