XPR Printer Redundancy
FDA 510(k) K914444 · Vortech Data, Inc.
510(k) numberK914444
Submission
- Device name
- XPR Printer Redundancy
- Applicant
- Vortech Data, Inc.
Reston, VA, US - Received
- October 4, 1991
- Decision date
- February 27, 1992
- 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…
Other 510(k)s with product code LMD
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|---|---|---|---|
| K994329 | Iivs Integrated Image Viewing StationLMD · Traditional | Terarecon,Inc. | 05/26/2000SE |
| K992698 | Stentor, PageviewLMD · Traditional | Stentor, Inc. | 10/25/1999SE |
| K992426 | Raypax Web Clinical SystemLMD · Traditional | Samsung Sds Co., Ltd. | 10/13/1999SE |
| K992352 | ITR2000: Internet Teleradiology, Model Release 1.0LMD · Traditional | Inteleradiology, Inc. | 09/29/1999SE |
| K991537 | Samsung Raypax SystemLMD · Traditional | Samsung Sds Co., Ltd. | 07/06/1999SE |
| K984000 | Stealthserver Image Storage and Communication SystemLMD · Traditional | Surgical Navigation Technologies, Inc. | 01/12/1999SE |
| K974707 | ImagequestLMD · Traditional | Visual Med, Inc. | 07/31/1998SE |
| 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 |
| K925097 | Vortech's Autorouter (Automatic Image Routing)LMD · Traditional | 01/15/1993SE |
| 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 |
| 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 XPR Printer Redundancy cleared by the FDA?
XPR Printer Redundancy (K914444) received a 510(k) decision of Substantially Equivalent on February 27, 1992, 146 days after the submission was received.
What is the product code of K914444?
The FDA product code is LMD – System, Digital Image Communications, Radiological, a Class I (low risk) device regulated under 21 CFR 892.2020.