Vortech's Autorouter (Automatic Image Routing)
FDA 510(k) K925097 · Vortech Data, Inc.
Submission
- Device name
- Vortech's Autorouter (Automatic Image Routing)
- Applicant
- Vortech Data, Inc.
Richardson, TX, US - Received
- October 8, 1992
- Decision date
- January 15, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LMD – System, Digital Image Communications, Radiological
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 892.2020
- Specialty
- Radiology
A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, interfaces, and a communications protocol. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric…
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| K984000 | Stealthserver Image Storage and Communication SystemLMD · Traditional | Surgical Navigation Technologies, Inc. | 01/12/1999SE |
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| K981053 | Kodak Digital Sciences (KDS) Image ViewLMD · Traditional | Eastman Kodak Company | 06/18/1998SE |
| K980918 | JpacsLMD · Traditional | Philips Medical Systems (Cleveland), Inc. | 06/03/1998SE |
| K974882 | Downscan LTLMD · Traditional | Merlin Engineering Works, Inc. | 05/22/1998SE |
More from Merlin Engineering Works, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K924366 | Personal Display SystemLLZ · Traditional | 04/07/1993SE |
| K924229 | Vg-A MigLMD · Traditional | 11/27/1992SE |
| K922310 | Vortech's Personal Display SystemLLZ · Traditional | 07/30/1992SE |
| K915362 | Vortech's Film Digitizer, FD-1KPR · Traditional | 04/06/1992SE |
| 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 Autorouter (Automatic Image Routing) cleared by the FDA?
Vortech's Autorouter (Automatic Image Routing) (K925097) received a 510(k) decision of Substantially Equivalent on January 15, 1993, 99 days after the submission was received.
What is the product code of K925097?
The FDA product code is LMD – System, Digital Image Communications, Radiological, a Class I (low risk) device regulated under 21 CFR 892.2020.