510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K221592Substantially Equivalent

AVIEW Lung Nodule CAD

Coreline Soft Co., Ltd., Seoul, KR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K221592 is the FDA 510(k) clearance record for AVIEW Lung Nodule CAD, a class II device, cleared for Coreline Soft Co., Ltd. on under FDA product code OEB (Lung Computed Tomography System, Computer-Aided Detection). FDA's definition for product code OEB reads: "To assist radiologists in the review of multi-slice computed tomography (msct) exams of the chest and highlight potential nodules that the radiologist should review. A computer aided diagnosis, lung computed tomography system is a class 3...". FDA records list 12 510(k) clearances for Coreline Soft Co., Ltd., from to . As of , FDA records show no recalls naming K221592.

Clearance record

Decision date
Received
(267 days to decision)
Product code
OEB Lung Computed Tomography System, Computer-Aided Detection
Regulation
21 CFR 892.2050
Device class
Class II
Review panel
Radiology
Applicant
Coreline Soft Co., Ltd. 4, 5f (Yeonnam-Dong), 49 World Cup Buk-Ro 6-Gil,, Seoul, KR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OEB

Trailing 12 months
2 clearances under product code OEB in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code OEB, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260