510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K152859Substantially Equivalent

Portable X-ray System (Model: MINIX-V / MINIX-S)

Digimed Co., Ltd. (Digimed Corporation Until 31/12/2012), Seoul, KR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K152859 is the FDA 510(k) clearance record for Portable X-ray System (Model: MINIX-V / MINIX-S), a class II device, cleared for Digimed Co., Ltd. (Digimed Corporation Until 31/12/2012) on under FDA product code EHD (Unit, X-Ray, Extraoral With Timer). FDA records list one 510(k) clearance for Digimed Co., Ltd. (Digimed Corporation Until 31/12/2012). As of , FDA records show no recalls naming K152859.

Clearance record

Decision date
Received
(64 days to decision)
Product code
EHD Unit, X-Ray, Extraoral With Timer
Regulation
21 CFR 872.1800
Device class
Class II
Review panel
Dental
Applicant
Digimed Co., Ltd. (Digimed Corporation Until 31/12/2012) 309-311, 318-Ho, 145, Grasan Digital 1-Ro, Geumcheon-Gu, Seoul, KR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EHD

Trailing 12 months
6 clearances under product code EHD in the twelve months to October 2026, February 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code EHD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20262
March 20262
April 20260
May 20261
June 20260
July 20260
August 20260
September 20261
October 20260