Who else makes this device?

Name: Hermia Multimodality Viewer
Brand: Hermia Multimodality Viewer

Radiology › DiagnosticSystem, Tomography, Computed, Emission

Hermia Multimodality Viewer

Affinity is a software application for nuclear medicine and radiology. Based on user input, Affinity processes, displays and analyzes nuclear medicine and radiology imaging data and…

Registry build 21.09.26

Affinity is a software application for nuclear medicine and radiology. Based on user input, Affinity processes, displays and analyzes nuclear medicine and radiology imaging data and presents the results to the user. The results can be stored for future analysis. The software application can be configured based on user needs. The investigation of physiological or pathological states using measurement and analysis functionality provided by Affinity is not intended to replace visual assessment. The information obtained from viewing and/or performing quantitative analysis on the images is used, in conjunction with other patient related data, to inform clinical management.

4manufacturers in China registered for this device type

1catalogue number

13510(k) clearances naming this product code

1recall

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 Hermia Multimodality Viewer
Listed by	Hermes Medical Solutions, AB, Sweden
FDA product code	KPS
Device type	System, Tomography, Computed, Emission
Device class	Class 2
Regulation	21 CFR 892.1200
Establishment	Complaint-file establishment, Manufacturer
Record published	2023-07-03
Record revised	2026-03-11 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	manufacturing date

Catalogue Numbers

Catalogue numbers for Hermia Multimodality Viewer
Catalogue number	Size	Status
00859873006172		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

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K252477	2025-09-09
K241364	2024-11-08
K202882	2020-12-23
K193152	2020-02-14
K181468	2018-10-25
K171719	2017-11-21
K171681	2017-11-21
K163394	2017-05-22
K153056	2016-06-01
K142631	2014-12-18
K140269	2014-05-08
K131233	2013-07-16
K121278	2012-12-18

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
2024-10-31	Class II	Device Design	Due a potential software/configuration issue that may result is incorrect alignment during reconstructing a SPECT/CT study.	778 systems

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.