Vortech's Film Digitizer, FD-1
FDA 510(k) K915362 · Vortech Data, Inc.
510(k) numberK915362
Submission
- Device name
- Vortech's Film Digitizer, FD-1
- Applicant
- Vortech Data, Inc.
Richardson, TX, US - Received
- November 27, 1991
- Decision date
- April 6, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K924229 | Vg-A MigLMD · Traditional | 11/27/1992SE |
| K922310 | Vortech's Personal Display SystemLLZ · Traditional | 07/30/1992SE |
| K914834 | Vortech 3M Network PrintingLMC · Traditional | 03/06/1992SE |
| K914444 | XPR Printer RedundancyLMD · Traditional | 02/27/1992SE |
| K914191 | XLP Network PrintingLMD · Traditional | 02/18/1992SE |
| K915094 | Vortech's Image Archival and Retrieval SystemLMB · Traditional | 12/27/1991SE |
| K913491 | Vortech's Personal Display SystemJAK · Traditional | 09/06/1991SE |
| K884434 | Vortech's Medical Imaging GatewayLMD · Traditional | 01/19/1989SE |
Questions and answers
When was Vortech's Film Digitizer, FD-1 cleared by the FDA?
Vortech's Film Digitizer, FD-1 (K915362) received a 510(k) decision of Substantially Equivalent on April 6, 1992, 131 days after the submission was received.
What is the product code of K915362?
The FDA product code is KPR – System, X-Ray, Stationary, a Class II (moderate risk) device regulated under 21 CFR 892.1680.