GeneralDevice clearance
LG Electronics Receives FDA 510(k) Clearance for 40HT513D Medical Monitor
FDA 510(k) — Radiology devices2w ago
FDA has cleared the LG Electronics 40HT513D medical monitor (product code PGY) for radiology use via 510(k) pathway. No performance numbers reported in clearance notice.
- Device: LG Electronics 40HT513D medical-grade display monitor, cleared under FDA product code PGY (picture archiving and diagnostic review monitors for radiology).
- Cleared via 510(k) substantial-equivalence pathway; no clinical performance data (sensitivity, specificity, luminance benchmarks) disclosed in the clearance summary.
- No predicate device or specific technical specifications (resolution, max luminance, intended diagnostic application tier) were reported in the source snippet.
RadPigeon summaries are original and for information only. They are not clinical advice.
