FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
SIGNA Artist Evo
K Number: K213603
·
Decision Feb 11, 2022
Classifications
1
FEI Numbers
146
Registration Numbers
146
Same Product Code
1098
Applicant Total
6
Review Days
88
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Basic Information
- Device Name
- SIGNA Artist Evo
- K Number
- K213603
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ge Healthcare (Tianjin) Company Limited
- Date Received
- November 15, 2021
- Decision Date
- February 11, 2022
- 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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Other Clearances by Ge Healthcare (Tianjin) Company Limited
| K Number | Device Name | ||
|---|---|---|---|
| K233728 | SIGNA Champion | Jan 19, 2024 | Substantially Equivalent |
| K223439 | SIGNA Victor | Feb 13, 2023 | Substantially Equivalent |
| K211980 | SIGNA Prime | Jan 16, 2022 | Substantially Equivalent |
| K202238 | SIGNA Artist | Sep 4, 2020 | Substantially Equivalent |
| K192426 | Signa Voyager, Signa Voyager Quantum | Oct 1, 2019 | Substantially Equivalent |