FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ERGO IMAGING SYSTEM
K Number: K100838
·
Decision Apr 23, 2010
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
129
Applicant Total
16
Review Days
30
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Basic Information
- Device Name
- ERGO IMAGING SYSTEM
- K Number
- K100838
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 892.1100
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Digirad Corp.
- Date Received
- March 24, 2010
- Decision Date
- April 23, 2010
- Product Code
- IYX
- 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 |
|---|---|---|---|
| IYX | Camera, Scintillation (Gamma) | FDA class 1 | Radiology |
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Other Clearances by Digirad Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K123408 | ERGO IMAGING SYSTEM | Jan 15, 2013 | 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 |
| K052430 | CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM | Oct 4, 2005 | 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 |