FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMT.LAB
K Number: K043360
·
Decision Jan 5, 2005
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
12
Review Days
29
Basic Information
- Device Name
- IMT.LAB
- K Number
- K043360
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- PIE MEDICAL
- Date Received
- December 7, 2004
- Decision Date
- January 5, 2005
- 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 PIE MEDICAL
| K Number | Device Name | ||
|---|---|---|---|
| K061961 | ART LAB SOFTWARE | Sep 6, 2006 | Substantially Equivalent |
| K053154 | MYLAB15/20 3D/4D ULTRASOUND IMAGING SYSTEM | Dec 16, 2005 | Substantially Equivalent |
| K043588 | MYLAB 15 / MYLAB 20, MODEL 2700 | Jan 25, 2005 | Substantially Equivalent |
| K041675 | PICUS, PARUS, FALCO AND AQUILA ULTRASOUND SYSTEMS | Jul 23, 2004 | Substantially Equivalent |
| K033604 | TRINGA ULTRASOUND IMAGING SYSTEM, MODEL 50L | Dec 15, 2003 | Substantially Equivalent |
| K023512 | PICUS ULTRASOUND IMAGING SYSTEMS | Jan 24, 2003 | Substantially Equivalent |
| K020112 | 50S TRINGA ULTRASOUND IMAGING SYSTEM | Apr 19, 2002 | Substantially Equivalent |
| K003725 | 240 PARUS ULTRASOUND IMAGING SYSTEMS, MODEL 240 PARUS | Mar 1, 2001 | Substantially Equivalent |
| K003292 | 260 CORVUS | Jan 5, 2001 | Substantially Equivalent |
| K002357 | 100 S AND 100 LC AND 485 ANSER ULTRASOUND IMAGING SYSTEMS | Nov 9, 2000 | Substantially Equivalent |