FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM
K Number: K052430
·
Decision Oct 4, 2005
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
470
Applicant Total
16
Review Days
28
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Basic Information
- Device Name
- CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM
- K Number
- K052430
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1200
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Digirad Corp.
- Date Received
- September 6, 2005
- Decision Date
- October 4, 2005
- Product Code
- KPS
- 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 |
|---|---|---|---|
| KPS | System, Tomography, Computed, Emission | FDA class 2 | Radiology |
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Other Clearances by Digirad Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K123408 | ERGO IMAGING SYSTEM | Jan 15, 2013 | Substantially Equivalent |
| K100838 | ERGO IMAGING SYSTEM | Apr 23, 2010 | Substantially Equivalent |
| K083649 | CARDIUS 3 X-ACT | Mar 9, 2009 | Substantially Equivalent |
| K082904 | STASYS MOTION CORRECTION SOFTWARE | Dec 17, 2008 | Substantially Equivalent |
| K082368 | CARDIUS-1, -2, -3, AND CARDIUS 1,2,3 XPO SPECT IMAGING SYSTEMS, 2020TC SPECT IMAGING SYSTEM | Sep 12, 2008 | Substantially Equivalent |
| K070542 | CARDIUS 1, 2 AND 3 XPO AND 2020TC SPECT IMAGING SYSTEMS | Mar 23, 2007 | Substantially Equivalent |
| K051549 | CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM | Jul 13, 2005 | Substantially Equivalent |
| K030085 | CARDIUS-1 AND CARDIS-2 | Feb 5, 2003 | Substantially Equivalent |
| K023110 | CEDARS-SINAI MOTION CORRECTION (MOCO) SOFTWARE, MODEL 111005 | Nov 22, 2002 | Substantially Equivalent |
| K011572 | QUANTITATIVE GATED SPECT (QGS), QUANTITATIVE PERFUSION SPECT (QPS) | Jun 15, 2001 | Substantially Equivalent |