Data / Medical devices / Sweden / Hermes Medical Solutions, AB

Hermes Medical Solutions, AB: FDA-registered device maker in Stockholm, Sweden, 8 510(k) clearances

Name: Hermes Medical Solutions, AB FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Hermes Medical Solutions, AB is registered with the FDA (registration 9710645) in Stockholm, Sweden. It lists 5 device types. The FDA files 8 510(k) clearances under its listings, the newest dated September 9, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 9710645
FEI number: 3002831423
Address: Strandbergsgatan 16, Stockholm, Sweden, SE-112 51
Owner or operator: HERMES MEDICAL SOLUTIONS AB (9047204)
Roles: Complaint file establishment, Manufacturer
First device listed: August 18, 2016
Registered through: 2026
Brand names listed: Affinity, GOLD Lx, Gold Smart WS, Hermes Medical Imaging Suite, Hermia, Hermia Multimodality Viewer, Hybrid Viewer, Hybrid3D and more

Devices it lists

Device	Product code	Class	Role	Source
Automated Radiological Image Processing Software	QIH	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Camera, Scintillation (Gamma)	IYX	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
System, Digital Image Communications, Radiological	LMD	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
System, Tomography, Computed, Emission	KPS	2	Complaint file establishment, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 9, 2025	K252477	Hybrid Viewer (00859873006240)	KPS	Substantially Equivalent	Hermes Medical Solutions AB	accessdata.fda.gov
July 30, 2025	K243919	Voxel Dosimetry (00859873006226)	QIH	Substantially Equivalent	Hermes Medical Solutions AB	accessdata.fda.gov
November 8, 2024	K241364	Hybrid Viewer (00859873006189)	KPS	Substantially Equivalent	Hermes Medical Solutions AB	accessdata.fda.gov
December 23, 2020	K202882	Affinity	KPS	Substantially Equivalent	Hermes Medical Solutions AB	accessdata.fda.gov
October 17, 2019	K191216	Voxel Dosimetry v1.0	LLZ	Substantially Equivalent	Hermes Medical Solutions AB	accessdata.fda.gov
October 25, 2018	K181468	Hybrid3D	KPS	Substantially Equivalent	Hermes Medical Solutions AB	accessdata.fda.gov
November 21, 2017	K171681	Hermes Medical Imaging Suite v5.7	KPS	Substantially Equivalent	Hermes Medical Solutions AB	accessdata.fda.gov
July 19, 2017	K163687	OLINDA EXM	IYX	Substantially Equivalent	Hermes Medical Solutions AB	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
October 31, 2024	95673	Class II	Ongoing	Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions affected are 4.0.0x and 5.0.0	Due a potential software/configuration issue that may result is incorrect alignment during reconstructing a SPECT/CT study.	accessdata.fda.gov

Compare with other makers

Updated September 9, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.