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
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K120520Substantially Equivalent

Exactrac Robotics Novalis Robotics

Brainlab, Inc., Feldkirchen, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K120520 is the FDA 510(k) clearance record for EXACTRAC ROBOTICS NOVALIS ROBOTICS, a class II device, cleared for Brainlab AG on under FDA product code JAI (Couch, Radiation Therapy, Powered). FDA records list 146 510(k) clearances for Brainlab AG, from to . As of , FDA records show no recalls naming K120520.

Clearance record

Decision date
Received
(129 days to decision)
Product code
JAI Couch, Radiation Therapy, Powered
Regulation
21 CFR 892.5770
Device class
Class II
Review panel
Radiology
Applicant
Brainlab AG Kapellenstrasse 12, Feldkirchen, DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JAI

Trailing 12 months

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

FDA records show no clearances under product code JAI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JAI, 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