FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QED DIODE DETECTORS, MODELS 1112-1116
K Number: K011466
·
Decision Jun 6, 2001
Classifications
1
FEI Numbers
146
Registration Numbers
146
Same Product Code
1098
Applicant Total
13
Review Days
23
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Basic Information
- Device Name
- QED DIODE DETECTORS, MODELS 1112-1116
- K Number
- K011466
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sun Nuclear Corp.
- Date Received
- May 14, 2001
- Decision Date
- June 6, 2001
- Product Code
- LNH
- 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 |
|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | FDA class 2 | Radiology |
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|---|---|---|---|
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| K092019 | MODEL 1014 PC ELECTROMETER | Sep 15, 2009 | Substantially Equivalent |
| K063021 | PROFILER 2 | Nov 22, 2006 | Substantially Equivalent |
| K051921 | THE EDGE DETECTOR, MODEL 1118 | Jul 27, 2005 | Substantially Equivalent |
| K013689 | RE-ENTRANT CHAMBER | Jul 2, 2002 | Substantially Equivalent |
| K021463 | MODEL 1133 IVD PC VERSION | Jun 6, 2002 | Substantially Equivalent |
| K011332 | RF-IVD WIRELESS DOSIMETER-MODEL 1133 | Jul 26, 2001 | Substantially Equivalent |
| K010449 | IVD (IN VIVO DOSIMETER), MODEL 1131 | May 4, 2001 | Substantially Equivalent |
| K002446 | RE-ENTRANT CHAMBER, MODEL 1008 OR 44D | Oct 23, 2000 | Substantially Equivalent |