FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
JETSTREAM WORKSPACE
K Number: K061029
·
Decision May 1, 2006
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
88
Review Days
17
Basic Information
- Device Name
- JETSTREAM WORKSPACE
- K Number
- K061029
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ADAC LABORATORIES
- Date Received
- April 14, 2006
- Decision Date
- May 1, 2006
- Product Code
- LLZ
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- Y
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 ADAC LABORATORIES
| K Number | Device Name | ||
|---|---|---|---|
| K062298 | APOLLO GAMMA CAMERA SYSTEM | Aug 23, 2006 | Substantially Equivalent |
| K060020 | AUTOQUANT PLUS | Jan 20, 2006 | Substantially Equivalent |
| K051351 | PRECEDENCE SPECT/CT IMAGING SYSTEM | Jun 8, 2005 | Substantially Equivalent |
| K042880 | JETSTREAM WORKSPACE | Nov 3, 2004 | Substantially Equivalent |
| K042903 | AUTOSPECS | Oct 29, 2004 | Substantially Equivalent |
| K041577 | PINNACLE3 RADIATION THERAPY PLANNING SYSTEM | Jun 25, 2004 | Substantially Equivalent |
| K041218 | GRIFFIN SPECT/CT IMAGING SYSTEM | May 24, 2004 | Substantially Equivalent |
| K041182 | SYNTEGRA | May 21, 2004 | Substantially Equivalent |
| K040326 | AUTOQUANT PLUS | Feb 25, 2004 | Substantially Equivalent |
| K040142 | ENSPHERE TEMPO JETSTREAM WORKSPACE CARDIOLOGY MODULE | Feb 6, 2004 | Substantially Equivalent |