(73 days)
No
The document describes an upgrade package for a CT system, focusing on hardware components (Rapidview Reconstructor, interface package) and capabilities (slice thickness, table speeds). There is no mention of AI, ML, or related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML algorithms. The "Rapidview Reconstructor" is mentioned, which is a common component in CT systems for image reconstruction, but this alone does not indicate AI/ML.
No.
The document describes an upgrade package for a CT imaging system. CT systems are diagnostic devices used to create images of the body, not to provide therapy.
Yes
The device is an upgrade package for a CT system, which is a common diagnostic imaging modality used to produce images for diagnosis.
No
The device is described as an "upgrade package" comprised of "components and capabilities" including a "Rapidview Reconstructor" and an "interface package." While it includes software capabilities (like slice thickness and table speeds), the description strongly suggests it includes hardware components as part of the upgrade to the existing CT system. The term "components" typically implies hardware in this context.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The description explicitly states that the upgrade "does not alter the intended use of the CT system to which it is attached." CT systems are imaging devices used for diagnostic purposes in vivo (within the living body), not in vitro (outside the body, typically on biological samples).
- Device Description: The components and capabilities described (Rapidview Reconstructor, slice thickness, table speeds) are all related to the acquisition and processing of medical images from a CT scan, which is an in vivo procedure.
- Input Imaging Modality: The input is a "Computed Tomography X-ray System," which is an in vivo imaging modality.
IVD devices are typically used to examine specimens such as blood, urine, or tissue to detect diseases, conditions, or infections. This device is clearly designed to enhance the capabilities of a medical imaging system used on patients.
N/A
Intended Use / Indications for Use
The AV Expander Upgrade does not alter the intended use of the CT system to which it is attached, nor does it differ from the SR8000.
Product codes
Not Found
Device Description
The Philips Tomoscan AV Expander Upgrade is an upgrade package to be installed on the existing Tomoscan SR 7000 (K924082). It is comprised of components and capabilities taken from the TOMOSCAN AVE CT system which has been cleared for commercial distribution by Premarket Notification submission K954255.
Identified components of the Expander Upgrade are the Rapidview Reconstructor, and an interface package; the included capabilities include a 7 mm slice thickness, and table speeds of 7 and 14 mm/sec. The AV Expander Upgrade does not alter the intended use of the CT system to which it is attached, nor does it differ from the SR8000. The resultant changes in specification do not affect clinical applications or effectiveness of the device. The X-ray tube and the different detectors will be the major difference between an upgraded SR 7000 and the Tomoscan AVE (SR 8000).
The AVE Upgrade is intended to address the primary operational differences between the Tomoscan SR 8000 and SR 7000:
Hardware/Software Content
-Rapidview Reconstructor
-Interface package (Net Interface) Functional Changes - I sec reconstruction
-7 mm slice thickness.
-Table speeds of 7 and 14 mm/sec
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography X-ray System
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic 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 generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the Philips logo. The logo consists of the word "PHILIPS" in a sans-serif font above a circular emblem. The emblem contains two stars, one at the top and one at the bottom, and two wavy lines in the center, all enclosed within a circle.
Image /page/0/Picture/1 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The letters are black and appear to be slightly distressed or textured, giving them a somewhat rough or aged appearance. The background is white, providing a clear contrast that makes the word easily readable.
JAN 1 0 1997
Philips Medical Systems
K9244318
Summary of Safety and Effectiveness
| CLASSIFICATION NAME: | Computed Tomography X-ray System
Class II -21 CFR 892.1750 |
|-------------------------|---------------------------------------------------------------|
| COMMON/USUAL NAME: | CT X-ray System |
| TRADE/PROPRIETARY NAME: | Philips TOMOSCAN AVE Upgrade |
| ESTABLISHMENT No. | 1217116 |
| PERFORMANCE STANDARDS: | 21 CFR Part 1020.33, IEC-601, and UL-187. |
SYSTEM DESCRIPTION:
The Philips Tomoscan AV Expander Upgrade is an upgrade package to be installed on the existing Tomoscan SR 7000 (K924082). It is comprised of components and capabilities taken from the TOMOSCAN AVE CT system which has been cleared for commercial distribution by Premarket Notification submission K954255.
Identified components of the Expander Upgrade are the Rapidview Reconstructor, and an interface package; the included capabilities include a 7 mm slice thickness, and table speeds of 7 and 14 mm/sec. The AV Expander Upgrade does not alter the intended use of the CT system to which it is attached, nor does it differ from the SR8000. The resultant changes in specification do not affect clinical applications or effectiveness of the device. The X-ray tube and the different detectors will be the major difference between an upgraded SR 7000 and the Tomoscan AVE (SR 8000).
The AVE Upgrade is intended to address the primary operational differences between the Tomoscan SR 8000 and SR 7000:
Hardware/Software Content
-Rapidview Reconstructor -Interface package (Net Interface) Functional Changes - I sec reconstruction -7 mm slice thickness. -Table speeds of 7 and 14 mm/sec
SAFETY INFORMATION:
Computed Tomography is a mature technology with which the industry and users have many years of experience. These devices must comply with the appropriate sections of the Radiation Control for Health and Safety Act. . A Product Report will be submitted prior to first delivery. Additionally, Philips CT systems are designed to be in compliance with National and International safety standards.
Philips Medical Systems
North America Company
710 Bridgeport Avenue
Shelton, CT 06484-4708
Tel: (203) 926-7674
Fax: (203) 929-6099