510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K172928Substantially Equivalent

Portable X-ray System

Rolence Enterprise Co., Ltd., Taoyuan, TW / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K172928 is the FDA 510(k) clearance record for Portable X-ray System, a class II device, cleared for Rolence Enterprise, Inc. on under FDA product code EHD (Unit, X-Ray, Extraoral With Timer). FDA records list 14 510(k) clearances for Rolence Enterprise, Inc., from to . As of , FDA records show no recalls naming K172928.

Clearance record

Decision date
Received
(172 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
Rolence Enterprise, Inc. 18-3, Ln. 231, Pu Chung Rd., Chungli, Taoyuan, TW
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