(29 days)
Not Found
No
The device description focuses on hardware components and traditional imaging techniques (X-ray, fluoroscopy). There is no mention of AI, ML, or related concepts in the provided text.
No
The device is an R/F system, which is used for imaging (diagnosis), not for therapy. It utilizes X-rays and includes components for image acquisition and processing.
Yes
The device is an R/F system, which is used for imaging, and the predicate device, Philips DIAGNOST 76 plus, is an X-ray diagnostic imaging system. This indicates its diagnostic purpose.
No
The device description clearly outlines a complex hardware system including a patient support table, spotfilm device, image intensifier, TV camera, X-ray tubes, generators, and optional ultrasound system. This is not a software-only device.
Based on the provided text, the Philips EasyDIAGNOST is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body. The description of the Philips EasyDIAGNOST clearly indicates it is an X-ray system used for imaging the inside of the body directly, not for analyzing samples taken from the body.
- The device description details hardware for generating and capturing X-ray images. This includes components like an X-ray tube, image intensifier, TV camera, and patient support table. These are characteristic of medical imaging systems, not IVD devices.
- The intended use is stated to be the same as the Philips DIAGNOST 76 plus (K924593). Looking up K924593 confirms it is a diagnostic X-ray system, further supporting that the EasyDIAGNOST is also an imaging device.
Therefore, the Philips EasyDIAGNOST is a medical imaging device, specifically an X-ray system, and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the Philips EasyDIAGNOST is the same as for the Philips DIAGNOST 76 plus.
Product codes
892.1980, 892.1670
Device Description
The Philips EasyDIAGNOST is a multi-functional R/F system consisting of a floormounted tilting patient support table and a spotfilm device holding an image intensifier and the TV camera. The tabletop can be moved by motor in longitudinal and lateral directions. The spot film device tilts with the table, and can be moved in three directions, relative to the table and to the patient. As a fully integrated system, it can be configured with generators from the Philips Medio, Super CP, and OPTIMUS families, with digital spot film cameras from the Philips DSI family, and with a Philips EASY VISION workstation. The system comes with a trimode Image Intensifier, XTV imaging system, Philips glass or metal X-ray tube(s), and TV monitor(s). An optional dedicated ultrasound system (Scanner 200X) can also be added.
The system can also be extended with an overtable tube which operates on a bucky tray inside the table and/or on a bucky wallstand (so-called second plane). This second plane option is identical to a Philips bucky DIAGNOST system, except for the table itself.
Philips Grid Controlled Fluoroscopy (GCF) can be provided using an SRM (metal) gridswitched X-ray tube. GCF improves overall image quality and provides dose reduction through precise control of fluoroscopic pulse shapes, eliminating excess radiation associated with pulse ramping and trailing effects of conventional pulsed fluoroscopy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
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
§ 892.1980 Radiologic table.
(a)
Identification. A radiologic table is a device intended for medical purposes to support a patient during radiologic procedures. The table may be fixed or tilting and may be electrically powered.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.
0
MAR 2 1 1997
510(k) Summary of Safety and Effectiness
In accordance with the requirements of the Safe Medical Device Act, Philips Medical Systems North America Company herewith submits a Summary of Safety and Effectiveness.
| CLASSIFICATION NAME: | Table 21CFR 892.1980 (90 IXR)
Spot Film Device 21CFR 892.1670 (90 IXL)
Class II |
|-------------------------|---------------------------------------------------------------------------------------|
| COMMON/USUAL NAME: | R/F System (R/F Table) |
| TRADE/PROPRIETARY NAME: | PHILIPS EasyDIAGNOST |
| ESTABLISHMENT No. | 1217116 |
PERFORMANCE STANDARDS:
This device complies with the federal X-Ray performance standards (CFR 1020.30, .31, .32) as well as with the relevant national and international standards for Electrical and Mechanical Safety (UL 187, IEC 601-1, IEC 601-2-7).
SYSTEM DESCRIPTION:
The Philips EasyDIAGNOST is a multi-functional R/F system consisting of a floormounted tilting patient support table and a spotfilm device holding an image intensifier and the TV camera. The tabletop can be moved by motor in longitudinal and lateral directions. The spot film device tilts with the table, and can be moved in three directions, relative to the table and to the patient. As a fully integrated system, it can be configured with generators from the Philips Medio, Super CP, and OPTIMUS families, with digital spot film cameras from the Philips DSI family, and with a Philips EASY VISION workstation. The system comes with a trimode Image Intensifier, XTV imaging system, Philips glass or metal X-ray tube(s), and TV monitor(s). An optional dedicated ultrasound system (Scanner 200X) can also be added.
The system can also be extended with an overtable tube which operates on a bucky tray inside the table and/or on a bucky wallstand (so-called second plane). This second plane option is identical to a Philips bucky DIAGNOST system, except for the table itself.
Philips Grid Controlled Fluoroscopy (GCF) can be provided using an SRM (metal) gridswitched X-ray tube. GCF improves overall image quality and provides dose reduction through precise control of fluoroscopic pulse shapes, eliminating excess radiation associated with pulse ramping and trailing effects of conventional pulsed fluoroscopy.
1
EQUIVALENCE INFORMATION:
The Philips EasyDIAGNOST is a modification of, and substantially equivalent to, the Philips DIAGNOST 76 plus manufactured by Philips Medical Systems. The DIAGNOST 76 plus received 510(k) clearance November 24, 1992 ( see 510(k) K924593). The DIAGNOST 76 plus was found substantially equivalent to the DIAGNOST 73, which is a pre-amendment device. The intended use of the Philips EasyDIAGNOST is the same as for the Philips DIAGNOST 76 plus. Both systems make use of equivalent technology.
SAFETY INFORMATION:
Througout the world, R/F systems are indispensible in daily practice for routine X-ray diagnosis. Industry and users have many years of experience with this type of equipment. The Philips EasyDIAGNOST uses mature technology and is designed to be in compliance with National and International safety standards.
The software used in the EasyDIAGNOST is equivalent to the software used in the predicate device.
The results of the hazard analysis, combined with the appropriate preventive measures taken indicate the device is of minor level of concern, as per the August 29, 1991 issue of the "Reviewers Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review".
Philips Medical Systems North America Company feels that sufficient information and data are contained in this submission to enable CDRH to reach a determination of substantial equivalence.