FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ADVANCED DIAGNOSTIC VIEWER (ADV)
K Number: K963697
·
Decision Nov 27, 1996
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
26
Review Days
72
Basic Information
- Device Name
- ADVANCED DIAGNOSTIC VIEWER (ADV)
- K Number
- K963697
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BIO-VASCULAR, INC.
- Date Received
- September 16, 1996
- Decision Date
- November 27, 1996
- Product Code
- LLZ
- 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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LLZ), ordered by most recent decision date.
CustomSurg OrthoPlanner
FDA 510(k)
FDA Class 2
·Radiology
uOmniscan
FDA 510(k)
FDA Class 2
·Radiology
Mosaic (V1.0.1)
FDA 510(k)
FDA Class 2
·Radiology
UroNav 4
FDA 510(k)
FDA Class 2
·Radiology
TechLive
FDA 510(k)
FDA Class 2
·Radiology
SMARTDent
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by BIO-VASCULAR, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K002233 | BVI SLING | Oct 13, 2000 | Substantially Equivalent |
| K992537 | PERI-STRIPS-SLEEVE, PERI-STRIPS-STRIP AND PERI-STRIPS DRY (NON-NAOH-TREATED AND NAOH-TREATED | Feb 22, 2000 | Substantially Equivalent |
| K983602 | CV PERI-GUARD AND VASCU-GUARD | Nov 12, 1998 | Substantially Equivalent |
| K983581 | OCU-GUARD AND OCU-GUARD SUPPLE | Nov 6, 1998 | Substantially Equivalent |
| K983162 | PERI-GUARD, CV PERI-GUARD, OCU-GUARD, SUPPLE PERI-GUARD, PERI-STRIPS - SLEEVE, PERI-STRIPS-STRIPS, PERI-STRIPS DRY, VASC | Oct 9, 1998 | Substantially Equivalent |
| K981624 | FLO-THRU | Aug 4, 1998 | Substantially Equivalent |
| K982282 | DURA-GUARD - DURAL REPAIR PATCH | Jul 30, 1998 | Substantially Equivalent |
| K971726 | CV PERI-GUARD - CARDIOVASCULAR PATCH | Apr 10, 1998 | Substantially Equivalent |
| K973706 | DURA-GUARD-DURAL REPAIR PATCH | Dec 24, 1997 | Substantially Equivalent |
| K973552 | OCU-GUARD ORBITAL IMPLANT WRAP, SUPPLE OCU-GUARD ORBITAL IMPLANT WRAP | Dec 16, 1997 | Substantially Equivalent |