FDA.reportPublic FDA data

OLINDA/EXM

Primary DI
00859873006035
Brand
OLINDA/EXM
Company
Hermes Medical Solutions AB
Model
00859873006035
Device description
The intended use of OLINDA/EXM is to provide estimates (deterministic) of absorbed radiation dose at the whole organ level as a result of administering any radionuclide and to calculate effective whole-body dose. This is dependent on input data regarding bio distribution being supplied to the application.
Published
2017-08-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYXCamera, Scintillation (Gamma)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYXCamera, Scintillation (Gamma)Radiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163687000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163687000OLINDA EXMHermes Medical Solutions AB2017-07-19IYX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859873006035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859873006035008598730060358598730060350859873006035

GMDN Terms#

Term, Definition table
TermDefinition
Nuclear medicine system workstationA freestanding, multi-purpose, image processing device that can be a component of one or more nuclear medicine imaging systems, e.g., a gamma camera, PET system or SPECT system. It is sometimes considered to be a component to a picture archiving and communication system (PACS). It does not contain the controls for the direct operation of the diagnostic imaging system. It can receive and transmit data both on-line and off-line and is typically located at a site remote from the operator's console. It has the capability to further process, manipulate and/or view patient images and information collected from one or more nuclear medicine based imaging systems.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1(252)3554372info@hermesmedical.com

Regulatory Flags#

DUNS number
354140220
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859873006219Hermia OLINDA008598730062192026-03-10
00859873006240Hermia008598730062402026-03-05
00859873006066Hermia Gold008598730060662017-11-30
00859873006189Hermia008598730061892024-12-10
00859873006172Hermia Multimodality Viewer008598730061722023-07-03
00859873006158Hermes Medical Imaging Suite008598730061582022-02-07
00859873006165Affinity008598730061652022-02-07
00859873006110Voxel Dosimetry008598730061102019-10-28
00859873006059Hermes Medical Imaging Suite008598730060592017-12-08
00859873006073Hybrid3D008598730060732017-12-08
00859873006080Hermia Gold008598730060802017-11-30
00859873006226Hermia008598730062262025-08-27
00859873006141Affinity2.02021-01-11
00859873006134Affinity1.02020-02-25
00859873006004HMS Medical Imaging Suite5.62016-09-19
00859873006028GOLD SMART WSv1.72016-10-20
00859873006042Hybrid 3D1.0P542017-06-05
00859873006011GOLD Lx1.62016-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00859873006219Hermia OLINDAHermes Medical Solutions ABIYX2026-03-10
00810149098215R&D Batteries, Inc.R & D Batteries, Inc.IYX2025-12-15
00810149098116R&D Batteries, Inc.R & D Batteries, Inc.IYX2025-10-15
B843UNISYN7510UniSynConvergent Imaging Solutions IncorporatedIYX2025-08-20
00810149098000R&D Batteries, Inc.R & D Batteries, Inc.IYX2025-07-14
00810149097966R&D Batteries, Inc.R & D Batteries, Inc.IYX2025-05-22
00810149097928R&D Batteries, Inc.R & D Batteries, Inc.IYX2025-03-04
00810149097799R&D Batteries, Inc.R & D Batteries, Inc.IYX2025-02-13
00810149097836R&D Batteries, Inc.R & D Batteries, Inc.IYX2025-02-13
00810149097843R&D Batteries, Inc.R & D Batteries, Inc.IYX2025-02-13
00810149097737R&D Batteries, Inc.R & D Batteries, Inc.IYX2025-01-29
00810149097713R&D Batteries, Inc.R & D Batteries, Inc.IYX2025-01-14
00810149097706R&D Batteries, Inc.R & D Batteries, Inc.IYX2025-01-07
00810149097683R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-12-13
00810149097690R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-12-13
00810149097638R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-11-05
00810149097621R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-11-04
00810149097607R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-10-22
00810149097584R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-10-17
00810149097546R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-09-12
00810149097522R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-09-06
00810149097409R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-08-09
00810149097287R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-06-18
00810149097270R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-04-15
00810149097263R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-03-05
00810149090073R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-01-01
00810149090141R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-01-01
00810149090158R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-01-01
00810149090196R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-01-01
00810149090202R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-01-01