Who else makes this device?

Name: Leksell Gamma Knife Esprit
Brand: Leksell Gamma Knife Esprit

Leksell Gamma Knife Esprit · System, Radiation Therapy, Radionuclide → Radiology

3manufacturers in China registered for this device type

1catalogue number

3510(k) clearances naming this product code

Who Else Makes It

Concentrated in Shaanxi (1), Guangdong (1), Hubei (1).

Chinese manufacturers registered for FDA product code IWB
Manufacturer	City	Province	Registered as	Device types
OUR United Corporation	Xian	Shaanxi	Contract manufacturer	2
Masep Medical Science & Technology DEVELOPMENT(SHENZHEN)Co.	Shenzhen	Guangdong	Manufacturer	2
OUR SMD Medical (Wuhan) Co., Ltd.	Wuhan	Hubei	Contract manufacturer	1

Record

Regulatory record for Leksell Gamma Knife Esprit
Listed by	Elekta Solutions AB, Sweden
FDA product code	IWB
Device type	System, Radiation Therapy, Radionuclide
Device class	Class 2
Regulation	21 CFR 892.5750
Establishment	Specification developer, Manufacturer, Exporter
Record published	2023-03-27
Record revised	2025-06-12 (version 2)

Specifications

Specifications
MRI safety	MR Unsafe
Prescription	Prescription only
Label carries	manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Leksell Gamma Knife Esprit
Catalogue number	Size	Status
1110200		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
GammaPod™ Breast Immobilization and Localization System	Xcision Medical Systems, LLC	42
Extend Frame system	Elekta Instrument AB	23
Clarity®	Elekta Solutions AB	11
Leksell Gamma Knife Icon	Elekta Instrument AB	9
Leksell Gamma Knife Perfexion/Icon	Elekta Instrument AB	9
Leksell Gamma Knife Perfexion/Icon	Elekta Solutions AB	5
Leksell Gamma Knife Icon	Elekta Solutions AB	4
GammaBeam	Best Theratronics Ltd.	2
Leksell Gamma Knife C 4 4C	Elekta Instrument AB	2
Isorad Detector, 15-25MV (-) 3m	Sun Nuclear Corporation	2
Leksell GammaPlan	Elekta Solutions AB	2
15-25 MV Isorad Detector (3m Cable)	Sun Nuclear Corporation	2

Showing 12 of 33. All products under System, Radiation Therapy, Radionuclide

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K250391	2025-07-02
K232854	2024-02-08
K222047	2022-10-26

Recalls Naming This Product

1 recall names this product by its own identifier, the UDI on its label.

Recalls naming the identifiers of Leksell Gamma Knife Esprit
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Elekta Inc.	UDI-DI	2026-02-18	Class II	Use error	Due to adapter not being properly aligned or locked in place.	352

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Leksell Gamma Knife Esprit