Vortech's Personal Display System
FDA 510(k) K922310 · Vortech Data, Inc.
510(k) numberK922310
Submission
- Device name
- Vortech's Personal Display System
- Applicant
- Vortech Data, Inc.
Richardson, TX, US - Received
- May 18, 1992
- Decision date
- July 30, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code LLZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262060 | 3D-RD-SLLZ · Traditional | Radiopharmaceutical Imaging & Dosimetry, LLC | 09/04/2026SE |
| K261500 | KBA3D (v2.4.0)LLZ · Traditional | S.M.A.I.O | 08/17/2026SE |
| K262449 | AdvaViewLLZ · Special | Advahealth Solutions, LLC | 08/14/2026SE |
| K261916 | NeuroQuant PETLLZ · Traditional | Cortechs Labs, Inc. | 08/12/2026SE |
| K260936 | RadioViewAILLZ · Traditional | Neurocareai, Inc. (Dba Savelife.Ai) | 07/31/2026SE |
| K260588 | Cleerly LABSLLZ · Traditional | Cleerly, Inc. | 07/29/2026SE |
| K262462 | TheraSphere 360 Y-90 Management PlatformLLZ · Special | Boston Scientific Corporation | 07/24/2026SE |
| K262143 | ImageGrid StreamVueLLZ · Traditional | Candelis, Inc. | 07/23/2026SE |
| K260500 | ResolutionMDLLZ · Traditional | ResolutionMD, Inc. | 07/21/2026SE |
| K262120 | Avara ViewerLLZ · Traditional | Avara Software | 07/10/2026SE |
More from Avara Software
| 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 |
| 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 Personal Display System cleared by the FDA?
Vortech's Personal Display System (K922310) received a 510(k) decision of Substantially Equivalent on July 30, 1992, 73 days after the submission was received.
What is the product code of K922310?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.