510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K002509Substantially Equivalent

Novalis (Shaped Beam Surgery System)

Brainlab, Inc., Heimstetten, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K002509 is the FDA 510(k) clearance record for NOVALIS (SHAPED BEAM SURGERY SYSTEM), a class II device, cleared for Brainlab AG on under FDA product code MUJ (System, Planning, Radiation Therapy Treatment). FDA records list 146 510(k) clearances for Brainlab AG, from to . As of , FDA records show one recall naming K002509.

Clearance record

Decision date
Received
(80 days to decision)
Product code
MUJ System, Planning, Radiation Therapy Treatment
Regulation
21 CFR 892.5050
Device class
Class II
Review panel
Radiology
Applicant
Brainlab AG Ammerthalstrasse 8, Heimstetten, DE
510(k) summary
Summary
Third party review
No

Clearances, product code MUJ

Trailing 12 months
12 clearances under product code MUJ in the twelve months to October 2026, December 2025 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code MUJ, trailing twelve months
MonthClearances
November 20251
December 20253
January 20260
February 20262
March 20261
April 20260
May 20263
June 20261
July 20261
August 20260
September 20260
October 20260