FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INSTASPOT
K Number: K942504
·
Decision May 5, 1995
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
8
Review Days
344
Basic Information
- Device Name
- INSTASPOT
- K Number
- K942504
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- FIDELITY MEDICAL, INC.
- Date Received
- May 26, 1994
- Decision Date
- May 5, 1995
- 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 FIDELITY MEDICAL, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K983088 | INSTACINE D-2000 | Sep 22, 1998 | Substantially Equivalent |
| K942558 | INSTACINE | May 30, 1995 | Substantially Equivalent |
| K941917 | FLUOROPLUA CARDIAC AND/OR INSTAVIEW | Feb 24, 1995 | Substantially Equivalent |
| K903774 | LP-PLUS | Aug 29, 1991 | Substantially Equivalent |
| K872928 | LP-3000 HIGH RESOLUTION ELECTROCARDIOGRAPH | Jan 6, 1988 | Substantially Equivalent |
| K864614 | LP-3 ELECTROCARDIOGRAPH | Jun 16, 1987 | Substantially Equivalent |
| K841780 | CLINICAL ELECTRONIC THERMOMETER | Jul 6, 1984 | Substantially Equivalent |