FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NORTHWESTERN GATED BLOOD POOL SPECT (NUMUGAS)
K Number: K020300
·
Decision Apr 23, 2002
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
470
Applicant Total
12
Review Days
84
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Basic Information
- Device Name
- NORTHWESTERN GATED BLOOD POOL SPECT (NUMUGAS)
- K Number
- K020300
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1200
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Syntermed, Inc.
- Date Received
- January 29, 2002
- Decision Date
- April 23, 2002
- 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 Syntermed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K130902 | EMORY CARDIAC TOOLBOX 3.2 | Jun 14, 2013 | Substantially Equivalent |
| K130451 | NEUROQ 3.6 | May 17, 2013 | Substantially Equivalent |
| K123646 | EMORY CARDIAC TOOLBOX 4.0 | Feb 22, 2013 | Substantially Equivalent |
| K072307 | QUANTITATIVE NEUROQ 3.0 | Mar 14, 2008 | Substantially Equivalent |
| K071503 | SYSTEM, TOMOGRAPHY, COMPUTED EMISSION | Jul 26, 2007 | Substantially Equivalent |
| K070089 | SYNTERMED LIVE | Mar 2, 2007 | Substantially Equivalent |
| K042258 | BP-SPECT V1.O | Oct 4, 2004 | Substantially Equivalent |
| K041022 | NEUROQ - PET DP | Jun 17, 2004 | Substantially Equivalent |
| K040141 | EMORY CARDIAC TOOLBOX VERSION 2.6 | Jan 30, 2004 | Substantially Equivalent |
| K014033 | EMORY CARDIAC TOOLBOX 2.1 EXECUTING ON NUCLEAR MEDICINE COMPUTERS | Feb 22, 2002 | Substantially Equivalent |