Vortech 3M Network Printing
FDA 510(k) K914834 · Vortech Data, Inc.
510(k) numberK914834
Submission
- Device name
- Vortech 3M Network Printing
- Applicant
- Vortech Data, Inc.
Richardson, TX, US - Received
- October 25, 1991
- Decision date
- March 6, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K914191 | XLP Network PrintingLMD · Traditional | 02/18/1992SE |
| K915094 | Vortech's Image Archival and Retrieval SystemLMB · Traditional | 12/27/1991SE |
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Questions and answers
When was Vortech 3M Network Printing cleared by the FDA?
Vortech 3M Network Printing (K914834) received a 510(k) decision of Substantially Equivalent on March 6, 1992, 133 days after the submission was received.
What is the product code of K914834?
The FDA product code is LMC – Camera, Multi Format, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2040.