LogoFDA 510(k) Search
K Number
K153056
Device Name
Hermes Medical Imaging Suite v5.6
Manufacturer
HERMES MEDICAL SOLUTIONS, AB
Date Cleared
2016-06-01

(224 days)

Product Code
KPS
Regulation Number
892.1200
Type
Traditional
Panel
RA
Reference & Predicate Devices
K142631,K131233,K130884
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

HERMES Medical Imaging Suite that provides software applications used to process, display, and manage nuclear medicine and other medical imaging data transferred from other workstation or acquistion stations.

Device Description

The Hermes Medical Imaging Suite provides software applications used to process, display, and manage nuclear medicine and other medical imaging data transferred from other workstation or acquisition stations.

AI/ML Overview

This submission for the Hermes Medical Imaging Suite v5.6 does not contain the information requested in your prompt.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It explicitly states that "The tests for verification and validation followed Hermes Medical Solutions AB design controlled procedures. The risk analysis concluded that all the software specifications have met the acceptance criteria." However, it does not provide any specific acceptance criteria, reported performance, or details about clinical studies (e.g., sample sizes, ground truth establishment, expert involvement, MRMC studies, or standalone performance).

The document primarily focuses on:

  • Identifying the device and its intended use.
  • Listing predicate devices (e.g., Hermes Medical Imaging Suite v5.5, v5.3, and Xeleris 3.1).
  • Stating that the new version (v5.6) has the "same technological characteristics as the original device and the same indication for use."
  • Mentioning that modifications include "transfer of BRASS DatScan support and Thyroid Analysis from the Old Hermes workstation (Oracle® SUN Solaris, see K130541) to the new platforms with Microsoft® Windows."

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, and performance measures based on the provided text.

§ 892.1200 Emission computed tomography system.

(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.