Lasershare Print SPOOLER(2100[SOLARIS X86]/(1500[WINDOWS Nt])
FDA 510(k) K973422 · Dejarnette Research Systems
510(k) numberK973422
Submission
- Device name
- Lasershare Print SPOOLER(2100[SOLARIS X86]/(1500[WINDOWS Nt])
- Applicant
- Dejarnette Research Systems
Towson, MD, US - Received
- September 10, 1997
- Decision date
- October 28, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Mitsubishi Electric Corporation Kyoto Works
| 510(k) | Device | Decision |
|---|---|---|
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| K973421 | Imageshare Computed Radiography Acquisition Station And/Or SOFTWARE(2100{SIKARUS…LMD · Traditional | 12/05/1997SE |
| K963861 | Lasershare Print Spooler And/Or SoftwareLMD · Traditional | 12/18/1996SE |
| K963628 | Imageshare Computed Radiography Acquisition Station And/Or SoftwareLMD · Traditional | 11/07/1996SE |
| 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(2100[SOLARIS X86]/(1500[WINDOWS Nt]) cleared by the FDA?
Lasershare Print SPOOLER(2100[SOLARIS X86]/(1500[WINDOWS Nt]) (K973422) received a 510(k) decision of Substantially Equivalent on October 28, 1997, 48 days after the submission was received.
What is the product code of K973422?
The FDA product code is LMC – Camera, Multi Format, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2040.