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K Number
K992731
Device Name
E.CAM COMPUTER
Manufacturer
SIEMENS MEDICAL SOLUTIONS USA, INC.
Date Cleared
1999-11-10

(89 days)

Product Code
KPS
Regulation Number
892.1200
Type
Traditional
Panel
RA
Reference & Predicate Devices
K952109,K892358
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

To detect or image the distribution of radionuclides in the body or organ, using the following techniques:

  • Planar İmaging .
  • . Whole body imaging
  • Tomographic imaging (SPECT) for non positron emitter .
  • . Positron imaging by coincidence
  • . Positron imaging without coincidence up to 588 keV
Device Description

Emission Computed Tomography System

AI/ML Overview

The provided text (K992731) describes the Siemens E.CAM Computer, an Emission Computed Tomography System. However, it does not contain the acceptance criteria or a study proving the device meets specific performance metrics.

This document is a 510(k) premarket notification for a medical device. Its primary purpose is to demonstrate substantial equivalence to previously legally marketed predicate devices, not to present a detailed performance study with acceptance criteria.

Therefore, I cannot fulfill the request to provide the acceptance criteria and the study details because that information is not present in the provided text.

Here's a breakdown of why the requested information is absent based on the document:

  • No Acceptance Criteria or Reported Performance Data: The document explicitly states "Performance Standard: None established under Section 514 of The Food. Drug and Cosmetic Act." This indicates that there are no specific, pre-defined performance thresholds for this type of device at the time of this submission that Siemens would need to meet and report against in this document. The submission focuses on demonstrating substantial equivalence.
  • No Study Details: The document refers only to "Substantial Equivalence" to previously marketed devices (K952109, K903315B, K892358). It does not describe any new study conducted by Siemens to establish specific performance metrics for the E.CAM Computer. The statement "The device labeling contains instructions for use. It includes indications for use and cautions. This information assures safe and effective use of the device" speaks to regulatory compliance and general safety rather than a specific performance study.

§ 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.