Imageshare Secondary Capture Acquisition Station And/Or Software (1000 Film Digitizer Acquisition Station)
FDA 510(k) K963594 · Dejarnette Research Systems
Submission
- Device name
- Imageshare Secondary Capture Acquisition Station And/Or Software (1000 Film Digitizer Acquisition Station)
- Applicant
- Dejarnette Research Systems
Towson, MD, US - Received
- September 9, 1996
- Decision date
- November 7, 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…
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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 |
| K963861 | Lasershare Print Spooler And/Or SoftwareLMD · Traditional | 12/18/1996SE |
| K963628 | Imageshare Computed Radiography Acquisition Station And/Or SoftwareLMD · 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 Imageshare Secondary Capture Acquisition Station And/Or Software (1000 Film Digitizer Acquisition Station) cleared by the FDA?
Imageshare Secondary Capture Acquisition Station And/Or Software (1000 Film Digitizer Acquisition Station) (K963594) received a 510(k) decision of Substantially Equivalent on November 7, 1996, 59 days after the submission was received.
What is the product code of K963594?
The FDA product code is LMD – System, Digital Image Communications, Radiological, a Class I (low risk) device regulated under 21 CFR 892.2020.