Who else makes this device?

Name: Corvus 09
Brand: Corvus 09

Radiology › TherapeuticSystem, Planning, Radiation Therapy Treatment

Corvus 09

CORVUS 09 is intended for use as a planning tool for conformal radiation therapy. CORVUS 09 is designed to generate plans for treatment delivery systems that can create multiple radiation…

Registry build 21.09.26

CORVUS 09 is intended for use as a planning tool for conformal radiation therapy. CORVUS 09 is designed to generate plans for treatment delivery systems that can create multiple radiation patterns composed of pencil beams on which the intensity can be individually controlled. CORVUS 09 system is intended to be used as an integrated system with a modulating device for planning and delivery of conformal radiation therapy.

5manufacturers in China registered for this device type

4catalogue numbers in this listing

4510(k) clearances naming this product code

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 Corvus 09
Listed by	Best Nomos, United States
FDA product code	MUJ
Device type	System, Planning, Radiation Therapy Treatment
Device class	Class 2
Regulation	21 CFR 892.5050
Establishment	Complaint-file establishment, Manufacturer
510(k)	K100092
Record published	2018-08-23

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Corvus 09
Catalogue number	Size	Status
210295		In distribution
210294		In distribution
210296		In distribution
210293		In distribution

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
Monaco	Elekta Solutions AB	4
XKnife®	Integra Lifesciences Corporation	4
Philips	Philips Medical Systems (Cleveland), Inc.	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
K211034	2021-05-06
K201350	2020-09-20
K151469	2015-11-25
K100092	2010-02-23

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.