What is FDA product code ORT?

Automatically mark or identify electroencephalograph waveforms for rhythmic patterns of burst suppression in order to aid in identification of such events and help in the review and annotation of prolonged EEG traces; software can also quantify simple characteristics of the burst suppression such as inter-burst interval or count; all output subject to verification by qualified user.

Neurology › DiagnosticBurst Suppression Detection Software For Electroencephalograph

Carescape B850

Name: Carescape B850
Brand: Carescape B850

Carescape B850 MBC313 (ATO Model)

Registry build 21.09.26

3manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

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

Chinese manufacturers registered for FDA product code ORT
Manufacturer	City	Province	Registered as	Device types
Amphenol Medical Technologies (Dongguan) Co., Ltd.	Dongguan	Guangdong	Contract manufacturer	77
Shenzhen Mindray BIO-Medical Electronics Co., Ltd.	Shenzhen	Guangdong	Specification developer	61
GE Medical Systems (China) Co., Ltd.	Wuxi	Jiangsu	Contract manufacturer	57

Record

Regulatory record for Carescape B850
Listed by	GE Healthcare Finland OY, Finland
FDA product code	ORT
Device type	Burst Suppression Detection Software For Electroencephalograph
Device class	Class 2
Regulation	21 CFR 882.1400
Establishment	Specification developer, Repacker / relabeller, Manufacturer
510(k)	K191323
Record published	2020-03-05
Record revised	2022-08-23 (version 4)

Specifications

Specifications
MRI safety	MR Unsafe
Label carries	manufacturing date, serial number
Storage	Storage environment atmospheric pressure 50 to 106 KiloPascal; Storage environment temperature -20 to 60 °C; Handling environment humidity 15 to 90 % RH; Storage environment humidity 10 to 90 % RH; Handling environment temperature 10 to 40 °C; Handling environment atmospheric pressure 70 to 106 KiloPascal

Catalogue Numbers

Catalogue numbers for Carescape B850
Catalogue number	Size	Status
MBC313		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Burst Suppression Detection Software For Electroencephalograph	GE Healthcare Finland OY	3
Carescape Canvas Smart Display	GE Healthcare Finland OY	1
Orthonol	RMO	1
CNS Envision	Natus Neurology Incorporated	1

Recalls Naming This Product

3 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.

Recalls naming the identifiers of Carescape B850
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
GE Healthcare Finland OY	510(k) number	2024-04-05	Class II	Software design	GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCAPE B850 and CARESCAPE B650 monitors if, following the replacement of the CPU tim	547 units
GE Healthcare Finland OY	UDI-DI	2024-04-05	Class II	Software design	GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCAPE B850 and CARESCAPE B650 monitors if, following the replacement of the CPU tim	54800 units
GE Healthcare Finland OY	UDI-DI	2024-04-05	Class II	Software design	GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCAPE B850 and CARESCAPE B650 monitors if, following the replacement of the CPU tim	25268 units

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.