510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K080540Substantially Equivalent

Neusoft Spiral CT Scanner System, Model Neuviz Version 2.0

Neusoft Medical Systems Co., Ltd., Shenyang, Liaoning, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080540 is the FDA 510(k) clearance record for NEUSOFT SPIRAL CT SCANNER SYSTEM, MODEL NEUVIZ VERSION 2.0, a class II device, cleared for Neusoft Medical Systems Co., Ltd. on under FDA product code JAK (System, X-Ray, Tomography, Computed). FDA records list 23 510(k) clearances for Neusoft Medical Systems Co., Ltd., from to . As of , FDA records show no recalls naming K080540.

Clearance record

Decision date
Received
(15 days to decision)
Product code
JAK System, X-Ray, Tomography, Computed
Regulation
21 CFR 892.1750
Device class
Class II
Review panel
Radiology
Applicant
Neusoft Medical Systems Co., Ltd. #3-11, Wenhua Rd., Shenyang, Liaoning, CN
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code JAK

Trailing 12 months
20 clearances under product code JAK in the twelve months to October 2026, March 2026 the highest month at 10.
Show the numbers
Monthly 510(k) clearances under FDA product code JAK, trailing twelve months
MonthClearances
November 20251
December 20250
January 20261
February 20260
March 202610
April 20260
May 20261
June 20262
July 20262
August 20260
September 20263
October 20260