ITR2000: Internet Teleradiology, Model Release 1.0
FDA 510(k) K992352 · Inteleradiology, Inc.
Submission
- Device name
- ITR2000: Internet Teleradiology, Model Release 1.0
- Applicant
- Inteleradiology, Inc.
San Marino, CA, US - Received
- July 14, 1999
- Decision date
- September 29, 1999
- 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 |
| 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 |
| K980684 | VR NetserveLMD · Traditional | I.S.G. Technologies, Inc. | 05/06/1998SE |
Questions and answers
When was ITR2000: Internet Teleradiology, Model Release 1.0 cleared by the FDA?
ITR2000: Internet Teleradiology, Model Release 1.0 (K992352) received a 510(k) decision of Substantially Equivalent on September 29, 1999, 77 days after the submission was received.
What is the product code of K992352?
The FDA product code is LMD – System, Digital Image Communications, Radiological, a Class I (low risk) device regulated under 21 CFR 892.2020.