510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K971001Substantially Equivalent

Autimo

Medizintechnik, GmbH, Rockville MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971001 is the FDA 510(k) clearance record for AUTIMO, a class II device, cleared for Medizintechnik, GmbH on under FDA product code IXI (Block, Beam-Shaping, Radiation Therapy). FDA records list one 510(k) clearance for Medizintechnik, GmbH. As of , FDA records show no recalls naming K971001.

Clearance record

Decision date
Received
(86 days to decision)
Product code
IXI Block, Beam-Shaping, Radiation Therapy
Regulation
21 CFR 892.5710
Device class
Class II
Review panel
Radiology
Applicant
Medizintechnik, GmbH 12300 Twinbrook Pkwy., Suite 625, Rockville MD
510(k) summary
Summary
Third party review
No

Clearances, product code IXI

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