FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DISCOVERY PET/CT 710
K Number: K133657
·
Decision Mar 21, 2014
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
459
Applicant Total
61
Review Days
114
Basic Information
- Device Name
- DISCOVERY PET/CT 710
- K Number
- K133657
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1200
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- GE MEDICAL SYSTEMS, LLC
- Date Received
- November 27, 2013
- Decision Date
- March 21, 2014
- 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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|---|---|---|---|
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| K142361 | Discovery MR750 3.0T | Dec 5, 2014 | Substantially Equivalent |
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| K141477 | DISCOVERY IQ | Sep 18, 2014 | Substantially Equivalent |
| K141074 | CORTEX ID SUITE | Sep 18, 2014 | Substantially Equivalent |
| K133705 | REVOLUTION CT | Apr 11, 2014 | Substantially Equivalent |
| K133640 | ASIR-V | Mar 25, 2014 | Substantially Equivalent |