510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K221955Substantially Equivalent

Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20

Realcloud Imaging Inc. dba Realcloud Imaging, Ames IA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K221955 is the FDA 510(k) clearance record for Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20, a class II device, cleared for Realcloud Imaging Inc. Dba Realcloud Imaging on under FDA product code MUH (System, X-Ray, Extraoral Source, Digital). FDA records list one 510(k) clearance for Realcloud Imaging Inc. Dba Realcloud Imaging. As of , FDA records show no recalls naming K221955.

Clearance record

Decision date
Received
(57 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
Realcloud Imaging Inc. Dba Realcloud Imaging 2625 N. Loop Dr., Suite 2130, Ames IA
510(k) summary
Summary PDF
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