510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K113732Substantially Equivalent

Iplan (Iplan Cranial, Iplan Stereotaxy, Iplan ENT, Iplan Cmf, Iplan View, Iplan Spine)

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

K113732 is the FDA 510(k) clearance record for IPLAN (IPLAN CRANIAL, IPLAN STEREOTAXY, IPLAN ENT, IPLAN CMF, IPLAN VIEW, IPLAN SPINE), a class II device, cleared for Brainlab AG on under FDA product code JAK (System, X-Ray, Tomography, Computed). FDA records list 146 510(k) clearances for Brainlab AG, from to . As of , FDA records show no recalls naming K113732.

Clearance record

Decision date
Received
(140 days to decision)
Product code
JAK System, X-Ray, Tomography, Computed
Regulation
21 CFR 892.1750
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 JAK

Trailing 12 months
21 clearances under product code JAK in the twelve months to November 2026, March 2026 the highest month at 10.
Show the numbers
Monthly 510(k) clearances under FDA product code JAK, trailing twelve months
MonthClearances
December 20250
January 20261
February 20260
March 202610
April 20260
May 20261
June 20262
July 20262
August 20260
September 20264
October 20261
November 20260