Konicaminolta DI-X1
FDA 510(k) K212685 · Konica Minolta, Inc.
510(k) numberK212685
Submission
- Device name
- Konicaminolta DI-X1
- Applicant
- Konica Minolta, Inc.
Hino-Shi, JP - Received
- August 24, 2021
- Decision date
- September 13, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Konicaminolta DI-X1 cleared by the FDA?
Konicaminolta DI-X1 (K212685) received a 510(k) decision of Substantially Equivalent on September 13, 2021, 20 days after the submission was received.
What is the product code of K212685?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.