FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THINKINGNET
K Number: K010271
·
Decision Apr 3, 2001
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
2
Review Days
64
Basic Information
- Device Name
- THINKINGNET
- K Number
- K010271
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- THINKING SYSTEMS CORP.
- Date Received
- January 29, 2001
- Decision Date
- April 3, 2001
- 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 |
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Other Clearances by THINKING SYSTEMS CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K120305 | THINKINGNET, THINKINGPACS/RIS - PROPRIETARY NAME FRO THINKINGNET, THINKINGARCHIVE (OR NUPAX) - THE MANAGEMENT AND ARCHIV | Jul 9, 2012 | Substantially Equivalent |