(90 days)
No
The description focuses on the hardware components and basic computer control for image reconstruction and system movement. There is no mention of AI, ML, or advanced image analysis techniques that would typically indicate the use of such technologies.
No
The device is described as a "whole body CT scanning system" intended for "diagnostic purposes, producing cross-sectional images of the body". It is used for imaging and diagnosis, not for treating a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is intended to be used as a Computed Tomography X-ray System for diagnostic purposes".
No
The device description clearly outlines numerous hardware components including a gantry, patient table, operating console, X-ray generator, detector array, motors, and power supplies. This is a physical medical device with integrated software, not a software-only device.
Based on the provided information, the Anatom 2000 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it is a "Computed Tomography X-ray System for diagnostic purposes, producing cross-sectional images of the body through computer reconstruction of X-ray transmission data from the same axial plane taken at different angles." This describes an imaging device that works by transmitting X-rays through the body and creating images based on the attenuation of those X-rays.
- Device Description: The description details the physical components of a CT scanner (gantry, X-ray generator, detector, patient table, console). These are all components of an imaging system, not a device that analyzes samples taken from the body (which is what "in vitro" means - "in glass").
- Input Imaging Modality: The input is "Computed Tomography X-ray," which is an imaging modality, not a biological sample.
- Anatomical Site: The anatomical site is "whole body," indicating it is used to image the patient directly.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment. The Anatom 2000 operates by imaging the body directly using X-rays.
N/A
Intended Use / Indications for Use
The Anatom 2000 is a whole body CT scanning system. It is intended to be used as a Computed Tomography X-ray System for diagnostic purposes, producing cross-sectional images of the body through computer reconstruction of X-ray transmission data from the same axial plane taken at different angles. This type of system has been classified as a Class II device under 21 CFR 892.1750.
Product codes
JAK
Device Description
The Anatom 2000 consists of a light weight gantry with built-in computer and power supplies, patient table, and operating console with display. The gantry uses a translatable rotating disk with X-ray generator and tube, pre-collimator, 384-element solid state detector array, control computer, energy storage banks, communications link, data acquisition, and power management and power supply electronics. The gantry is driven by a brushless DC motor. The gantry can be tilted +30/-25 degrees from the vertical and can translate horizontally approximately +7" (+178mm) for a total travel distance of approximately 14 inches (356mm). The high precision, highly stabilized X-ray generator is powered by sealed dry batteries which essentially eliminate dependence on AC line quality. The battery banks are charged in the stand-by mode from the main power source. Even when charging, the total line power is less than 1500 watts. The patient table connected to the gantry is driven by brushless DC motors for horizontal and vertical movement under microprocessor control. In the event of a power failure, the table top can be manually removed from the gantry opening so that the patient can be conveniently removed from the system.
The operator console or work station consists of a Sun Spare 5 computer and keyboard, 17" monitor, audio system, emergency controls, and uninterruptible power supply. The work station is responsible for the control-selection of the gantry, table, image processor, X-ray generator and tube.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography X-ray
Anatomical Site
whole body
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
510(k) Premarket Notification Number K944131
SUMMARY
(1) Submitted by:
Analogic Corporation Centennial Industrial Park 8 Centennial Drive Peabody, Ma. 01960
MAR - 6 1997
Phone: (508)977-3000, ext. 3316 Contact: James R. Levani November 27, 1996
- (2) Device Name: Anatom 2000, HA+ or A+ Model; current product (A models) are distributed by Philips Medical systems under the model names (Tomoscan M / EG). This product will also be sold by Philips. This system is the same as the current system, but with the additional capabilities or options of performing MPR and Helical Scanning. The system is classified as a Computed Tomography X-ray System, Product Code: JAK.
- Analogic Corporation Anatom 2000 (A) model; Philips Medical systems -(3) Predicate Device: (Tomoscan M / EG); K944131 (SE) 1/25/95.
- (4) Device Description: The Anatom 2000 consists of a light weight gantry with built-in computer and power supplies, patient table, and operating console with display. The gantry uses a translatable rotating disk with X-ray generator and tube, pre-collimator, 384-element solid state detector array, control computer, energy storage banks, communications link, data acquisition, and power management and power supply electronics. The gantry is driven by a brushless DC motor. The gantry can be tilted +30/-25 degrees from the vertical and can translate horizontally approximately +7" (+178mm) for a total travel distance of approximately 14 inches (356mm). The high precision, highly stabilized X-ray generator is powered by sealed dry batteries which essentially eliminate dependence on AC line quality. The battery banks are charged in the stand-by mode from the main power source. Even when charging, the total line power is less than 1500 watts. The patient table connected to the gantry is driven by brushless DC motors for horizontal and vertical movement under microprocessor control. In the event of a power failure, the table top can be manually removed from the gantry opening so that the patient can be conveniently removed from the system.
The operator console or work station consists of a Sun Spare 5 computer and keyboard, 17" monitor, audio system, emergency controls, and uninterruptible power supply. The work station is responsible for the control-selection of the gantry, table, image processor, X-ray generator and tube.
- (5) Intended Use: The Anatom 2000 is a whole body CT scanning system. It is intended to be used as a Computed Tomography X-ray System for diagnostic purposes, producing cross-sectional images of the body through computer reconstruction of X-ray transmission data from the same axial plane taken at different angles. This type of system has been classified as a Class II device under 21 CFR 892.1750.
- (6) In the opinion of Analogic Corporation, the Anatom 2000 Computed Tomographic X-ray System with the 2 additional options (HA+ / A+ model) is of comparable type in design, shape, materials, functionality and technology, and is substantially equivalent to the above indicated predicate device previously cleared through the 510(k) process under K944131.