Who else makes this device?

Name: SagiPlan® V.2.x Prostate Module Add-on SW
Brand: SagiPlan® V.2.x Prostate Module Add-on SW

Radiology › TherapeuticSystem, Planning, Radiation Therapy Treatment

SagiPlan® V.2.x Prostate Module Add-on SW

Catalogue number 1374-0610#01, listed by Eckert & Ziegler Bebig Gmbh, Germany, under System, Planning, Radiation Therapy Treatment. 5 manufacturers in China are registered for this product code.

Registry build 21.09.26

5manufacturers in China registered for this device type

1catalogue number

2510(k) clearances naming this product code

1recall

Who Else Makes It

Concentrated in Jiangsu (2), Fujian (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code MUJ
Manufacturer	City	Province	Registered as	Device types
Philips Healthcare (Suzhou) Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	5
Manteia Technologies Co., Ltd.	Xiamen	Fujian	Manufacturer	3
Masep Medical Science & Technology DEVELOPMENT(SHENZHEN)Co.	Shenzhen	Guangdong	Manufacturer	2
Suzhou Linatech Medical Science AND Technology Co., Ltd.	Suzhou	Jiangsu	Manufacturer	2
Varian Medical Systems China Co., Ltd.	Beijing	Beijing	Manufacturer	2

Record

Regulatory record for SagiPlan® V.2.x Prostate Module Add-on SW
Listed by	Eckert & Ziegler Bebig Gmbh, Germany
FDA product code	MUJ
Device type	System, Planning, Radiation Therapy Treatment
Device class	Class 2
Regulation	21 CFR 892.5050
Establishment	Manufacturer
Record published	2016-11-10
Record revised	2024-02-29 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	lot or batch number
Distribution end date	2024-02-28

Catalogue Numbers

Catalogue numbers for SagiPlan® V.2.x Prostate Module Add-on SW
Catalogue number	Size	Status
1374-0610#01		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
RayStation	RaySearch Laboratories AB (publ)	29
System, Planning, Radiation Therapy Treatment	Nucletron B.V.	17
Panther TPS	Prowess, Inc.	14
RayCare	RaySearch Laboratories AB (publ)	12
Accuray Precision® Treatment Planning System	Accuray Incorporated	7
Monaco	Elekta Inc.	7
Eclipse Treatment Planning System for External Beam Radiation Therapy	Varian Medical Systems, Inc	6
syngo.via RT Image Suite	Siemens Healthcare Limited	5
Eclipse Treatment Planning System	Varian Medical Systems, Inc	5
Corvus 09	Best Nomos	4
Monaco	Elekta Solutions AB	4
XKnife®	Integra Lifesciences Corporation	4

Showing 12 of 98. All products under System, Planning, Radiation Therapy Treatment

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K141900	2015-05-20
K123263	2013-04-04

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity
2023-10-17	Class II	Software Design Change	Due to software malfunction, numerical values may be rounded resulting in inaccurate measurements.	2 software licenses in US, 255 software licenses in OUS

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.