FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
CEDARA CARDIOLOGY VIEWER, CARDIOLOGY ARCHIVE VIEWER, CARDIOLOGY CD VIEWER
K Number: K002590
·
Decision Oct 31, 2000
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
5
Review Days
71
Basic Information
- Device Name
- CEDARA CARDIOLOGY VIEWER, CARDIOLOGY ARCHIVE VIEWER, CARDIOLOGY CD VIEWER
- K Number
- K002590
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CEDARA SOFTWARE CORP.
- Date Received
- August 21, 2000
- Decision Date
- October 31, 2000
- 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 CEDARA SOFTWARE CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K092915 | CEDARA WEBACCESS, MODEL: 2.4 | Jun 23, 2010 | Substantially Equivalent |
| K053301 | CEDARA I-RESPONSE CEDARA PET/CT | Feb 3, 2006 | Substantially Equivalent |
| K040468 | CEDARA I-SOFTVIEW AND CEDARA I-READMAMMO | Apr 23, 2004 | Substantially Equivalent |
| K022881 | CEDARA I-SOFTVIEW | Oct 22, 2002 | Substantially Equivalent |