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
K021718Substantially Equivalent

Intraoral Imaging System, Model Suni-Ray

Suni Imaging Microsystems, Inc., San Jose CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K021718 is the FDA 510(k) clearance record for INTRAORAL IMAGING SYSTEM, MODEL SUNI-RAY, a class II device, cleared for Suni Imaging Microsystems, Inc. on under FDA product code MUH (System, X-Ray, Extraoral Source, Digital). FDA records list one 510(k) clearance for Suni Imaging Microsystems, Inc. As of , FDA records show no recalls naming K021718.

Clearance record

Decision date
Received
(84 days to decision)
Product code
MUH System, X-Ray, Extraoral Source, Digital
Regulation
21 CFR 872.1800
Device class
Class II
Review panel
Dental
Applicant
Suni Imaging Microsystems, Inc. 6840 Via Del Oro, Suite 10, San Jose CA
510(k) summary
Statement
Third party review
No

Clearances, product code MUH

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