Patient Information Manager (Pim)
FDA 510(k) K921986 · Continental X-Ray Corp.
510(k) numberK921986
Submission
- Device name
- Patient Information Manager (Pim)
- Applicant
- Continental X-Ray Corp.
Broadview, IL, US - Received
- April 28, 1992
- Decision date
- October 16, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Patient Information Manager (Pim) cleared by the FDA?
Patient Information Manager (Pim) (K921986) received a 510(k) decision of Substantially Equivalent on October 16, 1992, 171 days after the submission was received.
What is the product code of K921986?
The FDA product code is IZH – System, X-Ray, Mammographic, a Class II (moderate risk) device regulated under 21 CFR 892.1710.