FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IMAGESSSHARE 910
K Number: K925284
·
Decision Jan 21, 1993
Classifications
1
FEI Numbers
148
Registration Numbers
148
Same Product Code
141
Applicant Total
9
Review Days
93
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Basic Information
- Device Name
- IMAGESSSHARE 910
- K Number
- K925284
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.2020
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dejarnette Research Systems
- Date Received
- October 20, 1992
- Decision Date
- January 21, 1993
- Product Code
- LMD
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LMD | System, Digital Image Communications, Radiological | FDA class 1 | Radiology |
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Other Clearances by Dejarnette Research Systems
| K Number | Device Name | ||
|---|---|---|---|
| K974130 | VISISHARE IMAGING SYSTEM AND/ OR SOFTWARE, VISISHARE SYSTEM AND/ OR SOFTWARE | Jan 29, 1998 | Substantially Equivalent |
| K973421 | IMAGESHARE COMPUTED RADIOGRAPHY ACQUISITION STATION AND/OR SOFTWARE(2100{SIKARUS X86}/(1500{WINDOWS NT} | Dec 5, 1997 | Substantially Equivalent |
| K973422 | LASERSHARE PRINT SPOOLER(2100[SOLARIS X86]/(1500[WINDOWS NT]) | Oct 28, 1997 | Substantially Equivalent |
| K963861 | LASERSHARE PRINT SPOOLER AND/OR SOFTWARE | Dec 18, 1996 | Substantially Equivalent |
| K963628 | IMAGESHARE COMPUTED RADIOGRAPHY ACQUISITION STATION AND/OR SOFTWARE | Nov 7, 1996 | Substantially Equivalent |
| K963594 | IMAGESHARE SECONDARY CAPTURE ACQUISITION STATION AND/OR SOFTWARE (1000 FILM DIGITIZER ACQUISITION STATION) | Nov 7, 1996 | Substantially Equivalent |
| K963592 | IMAGESHARE PROTOCOL CONVERTING GATEWAY AND/OR SOFTWARE [OS/2 WARP] 1OOO,[SUN/SOLARIS] 2000 | Nov 7, 1996 | Substantially Equivalent |
| K925793 | TELESHARE 910 | Feb 26, 1993 | Substantially Equivalent |