Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9710645

FEI Number

3002831423

Entity Name

HERMES MEDICAL SOLUTIONS, AB

City/State/Country

STOCKHOLM, SE

Establishment Address

Strandbergsgatan 16, STOCKHOLM SE-112 51, SE

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

HERMES MEDICAL SOLUTIONS AB (Owner Number: 9047204)

Owner / Operator Contact Address

Strandbergsgatan 16, --, STOCKHOLM, SE-AB 11251, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K252477

PMA Number

N/A

All Registered Proprietary Names

OLINDA OLINDA/EXM Hermia Voxel Dosimetry Hermia GOLD Lx Hermia Gold Smart WS Voxel Dosimetry Hermia Hermia Hybrid Viewer Hermes Medical Imaging Suite Hybrid Viewer Hermia

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IYX	Camera, Scintillation (Gamma)	Radiology	Class 1	892.1100	2017-07-23
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2019-10-23
LMD	System, Digital Image Communications, Radiological	Radiology	Class 1	892.2020	2016-08-18
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2025-08-25
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2025-08-25
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2025-03-10
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2017-11-30
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2025-11-26

Official Correspondent

No official correspondent registered.

US Agent Details

Christine Dempsey Business: Hermes Medical Solutions Inc Email: christine@hermesmedical.com Phone: (252) 7510664

Related Public Records

Same Entity

HERMES MEDICAL SOLUTIONS AB

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K080013	Agfa Healthcare Corporation	REGISTRATION AND FUSION	2008-01-17
K042221	Barco NV Barcoview	CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM	2004-12-30
K092915	Cedara Software Corp.	CEDARA WEBACCESS, MODEL: 2.4	2010-06-23
K961871	Siemens Medical Solutions USA, Inc.	FLOUROSPOT T.O.P.	1996-07-31
K122260	Aycan Digitalsysteme GmbH	AYCAN MOBILE	2012-09-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2022	GE Healthcare, LLC	2	Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016	GE Healthcare	2	Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026	CHANGE HEALTHCARE CANADA COMPANY	2	Change Healthcare Radiology Solutions software version 14.2.2
Z-0032-2012	Philips Healthcare Inc.	2	MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
Z-0033-2007	AGFA Corp.	2	IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

Similar Registrations

Registration Number	Establishment Name	Location
3023006704	SMARTBREAST CORPORATION, INC.	Sherman Oaks, CA, US
3030186509	X3D APS	Kvistgaard Hovedstaden, DK
3017754782	RADIOPHARMACEUTICAL IMAGING & DOSIMETRY, LLC	Baltimore, MD, US
3014954414	CONVERGENT IMAGING SOLUTIONS	Ottawa Ontario, CA
3027338963	GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING	Haifa, IL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9710645. Last updated year: 2026. Please use registration number 9710645 when referencing this establishment in official correspondence.