510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K201162Substantially Equivalent

Essence 55SP Large Monitor System

Shenyang Torch-Bigtide Digital Technology Co., Ltd., Shenyang, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K201162 is the FDA 510(k) clearance record for Essence 55SP Large Monitor System, a class II device, cleared for Shenyang Torch-Bigtide Digital Technology Co., Ltd. on under FDA product code DXJ (Display, Cathode-Ray Tube, Medical). FDA records list 2 510(k) clearances for Shenyang Torch-Bigtide Digital Technology Co., Ltd., from to . As of , FDA records show no recalls naming K201162.

Clearance record

Decision date
Received
(119 days to decision)
Product code
DXJ Display, Cathode-Ray Tube, Medical
Regulation
21 CFR 870.2450
Device class
Class II
Review panel
Cardiovascular
Applicant
Shenyang Torch-Bigtide Digital Technology Co., Ltd. # 18-6b, Yaoyang Rd., Huishan Economic Development Area, Shenyang, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DXJ

Trailing 12 months

FDA records hold no clearances under product code DXJ in the trailing twelve months.

FDA records show no clearances under product code DXJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DXJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260