(302 days)
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No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other indication of AI/ML use in the device description or performance studies.
No.
The device is described as an accessory for a Computed Tomography X-ray System, which is used to produce cross-sectional images of the body for diagnostic purposes, not for treating diseases or conditions.
Yes
The device is used in a Computed Tomography X-ray System to produce cross-sectional images of the body, which are then subject to computer reconstruction of x-ray transmission data. This process generates images that healthcare professionals use to understand the internal structures of the body, which is a key function of diagnostic devices.
No
The device description explicitly states it is an "Option" for a Computed Tomography X-ray System and "may include signal analysis and display equipment, patient equipment supports, components and accessories," indicating it is part of a larger hardware system and not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states the device is used in a Computed Tomography X-ray System to produce cross-sectional images of the body. This is an in vivo imaging process, meaning it's performed on a living organism (the patient).
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, outside of the body (in vitro).
The epi-Scope Option is a component of an imaging system that directly interacts with the patient to acquire data, which is the opposite of an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The epi-Scope Option will be used in a Computed Tomography X-ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This device may include signal analysis and display equipment, patient equipment supports, components and accessories.
Product codes
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Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Computed Tomography X-ray System
Anatomical Site
body
Indicated Patient Age Range
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Intended User / Care Setting
health care professionals
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Effectiveness is established by Picker's evaluation throughout all phases of the epi-Scope Option development. The product will perform in accordance with the development specifications.
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
MAR 2 1 1997
Picker 510(k) Notice
K96 2010
epi-Scope Option
Summary of Safety and Effectiveness
This is a summary of the information submitted by Picker International, Inc. to the Office of Device Evaluation (DRAERD) of the FDA as required by the Federal Food, Drug, and Cosmetic Act as amended on November 18, 1990 in section 513(f)(3) for the epi-Scope Option.
The epi-Scope Option will be used in a Computed Tomography X-ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This device may include signal analysis and display equipment, patient equipment supports, components and accessories.
Functional specifications and operator's instructions (preliminary) are included in the attachments. Final documentation will be provided with production units.
The epi-Scope Option is substantially equivalent to legally marketed device. The epi-Scope Option is under control of health care professionals who are trained and responsible for computed tomography examinations. The epi-Scope Option will be used in certified CT Systems that comply with Federal Diagnostic X-ray Performance Standards.
Picker adheres to FDA GMPs, 21 CFR 1020.30-31, voluntary standards for safety/effectiveness (UL 187) all of which mandate that components are tested to minimize hazards (electrical, mechanical, and radiation).
Effectiveness is established by Picker's evaluation throughout all phases of the epi-Scope Option development. The product will perform in accordance with the development specifications. The epi-Scope Option represents the current state-of- the-art technology, therefore, is equivalent to legally marketed Advantage 3D Navigator Option manufactured by General Electric in Document Control No. K954355.
Picker has reviewed all known information and performed an investigation as to the causes of safety/effectiveness concerning the epi-Scope Option. In addition, all information contained in this 510(k) Notice is accurate and complete.