Who else makes this device?

Name: Discovery NM 530c
Brand: Discovery NM 530c

Discovery NM 530c · System, Tomography, Computed, Emission → Radiology

4manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

Concentrated in Beijing (1), Shanghai (1), Guangdong (1).

Chinese manufacturers registered for FDA product code KPS
Manufacturer	City	Province	Registered as	Device types
GE Hangwei Medical Systems Co., Ltd.	Beijing	Beijing	Specification developer	22
Shanghai United Imaging Healthcare Co., Ltd.	Shanghai	Shanghai	Manufacturer	12
Siemens Shenzhen Magnetic Resonance Ltd.	Shenzhen	Guangdong	Contract manufacturer	8
Neusoft Positron Medical Systems Co., Ltd.	Shen Yang	Liaoning	Manufacturer	1

Record

Regulatory record for Discovery NM 530c
Listed by	G E Medical Systems Israel Ltd.
FDA product code	KPS
Device type	System, Tomography, Computed, Emission
Device class	Class 2
Regulation	21 CFR 892.1200
510(k)	K080124
Record published	2016-08-01
Record revised	2026-01-30 (version 5)

Specifications

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

Catalogue Numbers

Catalogue numbers for Discovery NM 530c
Catalogue number	Size	Status
H3000SA		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
NeuroQ	Syntermed, Inc.	11
Emory Cardiac Toolbox	Syntermed, Inc.	10
Discovery	GE Medical Systems, L.L.C.	7
uMI	Shanghai United Imaging Healthcare Co., Ltd.	7
Brightonix	Brightonix Imaging Inc.	6
UltraSPECT	Ultraspect USA, LLC	5
Discovery	G E Medical Systems Israel Ltd.	5
Veriton CT	Spectrum Dynamics Medical Ltd.	5
Cardius 2	Digirad Corp.	4
Encompass™ SRS Fibreplast™ System	Qfix	4
Veriton NM	Spectrum Dynamics Medical Ltd.	3
Cedars-Sinai Cardiac Suite	Cedars Sinai Medical Center	3

Showing 12 of 172. All products under System, Tomography, Computed, Emission

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 Discovery NM 530c
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
GE Medical Systems, LLC	UDI-DI	2022-06-02	Class II	Error in labeling	As a result of unclear guidance in the service manual, the table can drop during a specific service activity if the wrong screws are removed by the service personnel without the appropriate table supports in place resulting in injury to ser	24,843 tables
GE Medical Systems, LLC	510(k) number	2018-11-30	Class II	Other	GE Healthcare has identified that a small number of Nuclear Medicine systems are operating without currently updated software. In a recent event, a patient s finger was injured during the Unload process while the automatic Unload feature wa	526 total units
GE Medical Systems, LLC	510(k) number	2013-01-09	Class II	Device Design	GE Healthcare has recently become aware of an incident which caused a patient injury during an unload following an exam on a Ventri scanner. During a patient unload following a scan, the patients fingers may be pinched between the moving cr	556	2013-08-06

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.

Discovery NM 530c