GC85A— 510(k) K260481
Substantially EquivalentSamsung Electronics Co., Ltd.
FDA 510(k) clearance K260481 for GC85A, Substantially Equivalent on 2026-08-27. Applicant: Samsung Electronics Co., Ltd.. Device class: 2.
Summary
Samsung Electronics' GC85A is filed under product code KPR, stationary x-ray systems. The name is a model designation, and the record has no other description.
Class II, 21 CFR 892.1680. Radiology is both the classification panel and the review panel, and it was a Traditional 510(k).
Samsung filed from Suwon-Si, South Korea. The decision came 195 calendar days after FDA received it (February 13 to August 27, 2026): substantially equivalent.
Clearance details
- Applicant
- Samsung Electronics Co., Ltd.
- Product code
- Product code KPR
- Device class
- Class 2
- Regulation
- 21 CFR 892.1680
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Suwon-Si, KR
Recent devices under product code KPR
view all- K260227 — EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50H
- K260488 — MULTIX Impact; MULTIX Impact C
- K260482 — DRE Duo
- K253446 — AeroDR TX c02
- K250954 — DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector
More clearances from Samsung Electronics Co., Ltd.
view allAdverse events under product code KPR
product code KPR- Other
- 6
- Total
- 6
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.