510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K212051Substantially Equivalent

Rfa-1717Dig, Rfa-1717Dic

Astel, Inc., Daejeon, KR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K212051 is the FDA 510(k) clearance record for RFA-1717DIG, RFA-1717DIC, a class II device, cleared for Astel, Inc. on under FDA product code MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager)). FDA records list one 510(k) clearance for Astel, Inc. As of , FDA records show no recalls naming K212051.

Clearance record

Decision date
Received
(56 days to decision)
Product code
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Regulation
21 CFR 892.1680
Device class
Class II
Review panel
Radiology
Applicant
Astel, Inc. 26-79, Gajeongbuk-Ro, Yuseong-Gu, Daejeon, KR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MQB

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