GC85A
by Samsung Electronics Co., Ltd
510(k) K260481
GC85A is a Class II device made by Samsung Electronics Co., Ltd, cleared under FDA 510(k) K260481 on 27 Aug 2026, active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK260481 | Date27 Aug 2026 | StatusActive |
Official records
- FDA 510(k) database K260481
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KPR
- FDA applicant
- Samsung Electronics Co., Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1680
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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