Lasershare Print Spooler And/Or Software
FDA 510(k) K963861 · Dejarnette Research Systems
Submission
- Device name
- Lasershare Print Spooler And/Or Software
- Applicant
- Dejarnette Research Systems
Towson, MD, US - Received
- September 24, 1996
- Decision date
- December 18, 1996
- 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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K974130 | Visishare Imaging System And/ or Software, Visishare System And/ or SoftwareLMD · Traditional | 01/29/1998SE |
| K973421 | Imageshare Computed Radiography Acquisition Station And/Or SOFTWARE(2100{SIKARUS…LMD · Traditional | 12/05/1997SE |
| K973422 | Lasershare Print SPOOLER(2100[SOLARIS X86]/(1500[WINDOWS Nt])LMC · Traditional | 10/28/1997SE |
| K963628 | Imageshare Computed Radiography Acquisition Station And/Or SoftwareLMD · Traditional | 11/07/1996SE |
| K963594 | Imageshare Secondary Capture Acquisition Station And/Or Software (1000 Film Digitizer…LMD · Traditional | 11/07/1996SE |
| K963592 | Imageshare Protocol Converting Gateway And/Or Software [OS/2 Warp] 1OOO,[SUN/SOLARIS] 2000LMD · Traditional | 11/07/1996SE |
| K925793 | Teleshare 910LLZ · Traditional | 02/26/1993SE |
| K925284 | Imagessshare 910LMD · Traditional | 01/21/1993SE |
Questions and answers
When was Lasershare Print Spooler And/Or Software cleared by the FDA?
Lasershare Print Spooler And/Or Software (K963861) received a 510(k) decision of Substantially Equivalent on December 18, 1996, 85 days after the submission was received.
What is the product code of K963861?
The FDA product code is LMD – System, Digital Image Communications, Radiological, a Class I (low risk) device regulated under 21 CFR 892.2020.