GM85
FDA 510(k) clearance K222353 · decided 2022-09-29
Clearance details
- K-number
- K222353
- Device name
- GM85
- Applicant
- Samsung Electronics Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2022-08-04
- Decision date
- 2022-09-29
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- IZL
- Device class
- 2
- Regulation number
- 892.1720
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Suwon-Si, KR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| GM85 Digital Mobile X-ray imaging System; Model Number: GM85; recall (Z-0480-2026) | NeuroLogica Corporation | 2025-11-07 |
| Samsung Digital Diagnostic Mobile X-ray System, Model GM85. recall (Z-1056-2024) | NeuroLogica Corporation | 2024-02-09 |
| Samsung GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile X-ray System recall (Z-1414-2023) | NeuroLogica Corporation | 2023-04-19 |