FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GammaTile
K Number: K190296
·
Decision Mar 13, 2019
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
150
Applicant Total
3
Review Days
30
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Basic Information
- Device Name
- GammaTile
- K Number
- K190296
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.5730
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Gt Medical Technologies
- Date Received
- February 11, 2019
- Decision Date
- March 13, 2019
- Product Code
- KXK
- 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 |
|---|---|---|---|
| KXK | Source, Brachytherapy, Radionuclide | FDA class 2 | Radiology |
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