510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K944684Substantially Equivalent

Polyscan Digital Scanner

Mse Medizintechnik GmbH & Co. KG, Rodemark, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K944684 is the FDA 510(k) clearance record for POLYSCAN DIGITAL SCANNER, a class I device, cleared for Mse Medizintechnik GmbH & Co. KG on under FDA product code IYW (Scanner, Rectilinear, Nuclear). FDA records list one 510(k) clearance for Mse Medizintechnik GmbH & Co. KG. As of , FDA records show no recalls naming K944684.

Clearance record

Decision date
Received
(235 days to decision)
Product code
IYW Scanner, Rectilinear, Nuclear
Regulation
21 CFR 892.1300
Device class
Class I
Review panel
Radiology
Applicant
Mse Medizintechnik GmbH & Co. KG Carl Zeiss Strasses 18, D-6074, Rodemark, DE
510(k) summary
Statement
Third party review
No

Clearances, product code IYW

Trailing 12 months

FDA records hold no clearances under product code IYW in the trailing twelve months.

FDA records show no clearances under product code IYW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IYW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260