Resubmitted Scanora
FDA 510(k) K884650 · Orion Corp.
510(k) numberK884650
Submission
- Device name
- Resubmitted Scanora
- Applicant
- Orion Corp.
20101 Turku, FI - Received
- November 7, 1988
- Decision date
- March 16, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Resubmitted Scanora cleared by the FDA?
Resubmitted Scanora (K884650) received a 510(k) decision of Substantially Equivalent on March 16, 1989, 129 days after the submission was received.
What is the product code of K884650?
The FDA product code is IZF – System, X-Ray, Tomographic, a Class II (moderate risk) device regulated under 21 CFR 892.1740.