FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇦 Canada
VR NETSERVE
K Number: K980684
·
Decision May 6, 1998
Classifications
1
FEI Numbers
148
Registration Numbers
148
Same Product Code
141
Applicant Total
10
Review Days
72
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Basic Information
- Device Name
- VR NETSERVE
- K Number
- K980684
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.2020
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- I.S.G. Technologies, Inc.
- Date Received
- February 23, 1998
- Decision Date
- May 6, 1998
- 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 I.S.G. Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K993673 | SNN FLUORO NAVIGATION SYSTEM | Dec 21, 1999 | Substantially Equivalent |
| K982570 | SNN SCOUT | Jan 13, 1999 | Substantially Equivalent |
| K973413 | ID. STORE (RELEASE 2.0) | Nov 25, 1997 | Substantially Equivalent |
| K970865 | ISG FAMILY OF VIEWING WANDS | Jun 4, 1997 | Substantially Equivalent |
| K960714 | ISG VIEWING WAND | May 29, 1996 | Substantially Equivalent |
| K941933 | ISG MEDICAL IMAGING FAMILY OF WORKSTATIONS (MIFW) | Jul 29, 1994 | Substantially Equivalent |
| K911783 | ALLEGRO VIEWING WAND | Apr 7, 1994 | Substantially Equivalent |
| K901679 | RESUBMITTED ISG 3DMV WORKSTATION | May 29, 1990 | Substantially Equivalent |
| K872150 | I.S.G. 3DMV WORKSTATION | Aug 12, 1987 | Substantially Equivalent |