FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
RESOLUTIONMD CARDIAC PRODUCT FAMILY, MODEL: RELEASE 1.0
K Number: K071086
·
Decision Jun 1, 2007
Classifications
1
FEI Numbers
599
Registration Numbers
599
Same Product Code
2271
Applicant Total
8
Review Days
45
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Basic Information
- Device Name
- RESOLUTIONMD CARDIAC PRODUCT FAMILY, MODEL: RELEASE 1.0
- K Number
- K071086
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Calgary Scientific, Inc.
- Date Received
- April 17, 2007
- Decision Date
- June 1, 2007
- 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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| K120076 | RESOLUTIONMD WEB | Apr 19, 2012 | Substantially Equivalent |
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| K082693 | RESOLUTIONMD, RELEASE 2.1 | Feb 23, 2009 | Substantially Equivalent |
| K062164 | RESOLUTIONMD, VERSION 1.3 | Sep 22, 2006 | Substantially Equivalent |