510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K011111Substantially Equivalent

Mxd100/mx 20, or Mx 30, or Mx 40 or Mx 50--(Mxd 100 Series)

Modular X-Ray Devices, Roodepoort, ZA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011111 is the FDA 510(k) clearance record for MXD100/MX 20, OR MX 30, OR MX 40 OR MX 50--(MXD 100 SERIES), a class II device, cleared for Modular X-Ray Devices on under FDA product code KPR (System, X-Ray, Stationary). FDA records list one 510(k) clearance for Modular X-Ray Devices. As of , FDA records show no recalls naming K011111.

Clearance record

Decision date
Received
(49 days to decision)
Product code
KPR System, X-Ray, Stationary
Regulation
21 CFR 892.1680
Device class
Class II
Review panel
Radiology
Applicant
Modular X-Ray Devices P.O. Box 2878, Roodepoort, ZA
510(k) summary
Summary
Third party review
No

Clearances, product code KPR

Trailing 12 months
7 clearances under product code KPR in the twelve months to October 2026, August 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code KPR, trailing twelve months
MonthClearances
November 20251
December 20250
January 20261
February 20260
March 20260
April 20261
May 20260
June 20261
July 20260
August 20262
September 20261
October 20260