SIGNA Architect
FDA 510(k) clearance K202966 · decided 2020-11-13
Clearance details
- K-number
- K202966
- Device name
- SIGNA Architect
- Applicant
- Ge Healthcare (Ge Medical Systems, LLC)
- Decision
- Substantially Equivalent
- Date received
- 2020-09-30
- Decision date
- 2020-11-13
- Days to decision
- 44 days
- Clearance type
- Traditional
- Product code
- LNH
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Waukesha, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| GE SIGNA Architect, Nuclear Magnetic Resonance Imaging System recall (Z-2303-2025) | GE Medical Systems, LLC | 2025-08-13 |
| SIGNA Architect recall (Z-2130-2025) | GE Medical Systems, LLC | 2025-07-18 |
| SIGNA Architect, Nuclear Magnetic Resonance Imaging System recall (Z-0518-2025) | GE Medical Systems, LLC | 2024-11-22 |
| SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System recall (Z-0519-2025) | GE Medical Systems, LLC | 2024-11-22 |
| SIGNA Architect, with affected software versions: DV26.0 to DV26.3, DV27.0 to DV27.3, DV28 recall (Z-2459-2024) | GE Medical Systems, LLC | 2024-08-02 |
| SIGNA Architect nuclear magnetic resonance imaging system recall (Z-0133-2022) | GE Healthcare, LLC | 2021-10-16 |
| SIGNA Architect - Product Usage: is a whole body magnetic resonance scanner designed to su recall (Z-2053-2021) | GE Healthcare, LLC | 2021-07-12 |