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
K121963Substantially Equivalent

Planmed Nuance Digiguide

Planmed Oy, Helsinki, FI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K121963 is the FDA 510(k) clearance record for PLANMED NUANCE DIGIGUIDE, a class II device, cleared for Planmed OY on under FDA product code MUE (Full Field Digital, System, X-Ray, Mammographic). FDA records list 20 510(k) clearances for Planmed OY, from to . As of , FDA records show no recalls naming K121963.

Clearance record

Decision date
Received
(139 days to decision)
Product code
MUE Full Field Digital, System, X-Ray, Mammographic
Regulation
21 CFR 892.1715
Device class
Class II
Review panel
Radiology
Applicant
Planmed OY Asentajankatu 6, Helsinki, FI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MUE

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