(53 days)
No
The summary describes a traditional X-ray system with motorized components and programmed functions, with no mention of AI or ML.
No.
The device is described as an "x-ray diagnostic system" used for various examinations, indicating it is for diagnosis, not treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that it is an "x-ray diagnostic system."
No
The device description clearly outlines a physical X-ray system with motorized components (table tilt, telescoping arm) and the ability to perform linear tomography, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Siemens Siregraph CF is an X-ray system. It uses radiation to create images of the internal structures of the body. This is an in vivo diagnostic method (performed within the living body), not in vitro (performed outside the living body).
- Intended Use: The intended use clearly describes radiographic and fluoroscopic examinations of various anatomical sites. This involves imaging the patient directly, not analyzing samples from the patient.
Therefore, the Siemens Siregraph CF is a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Siemens Siregraph CF is a remote overtable radiographic/fluoroscopic x-ray diagnostic system that was designed for universal implementation in the hospital and clinical environment. The Siregraph CF, remote X-ray system, has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoraic and lung exposures as well as examinations of the urinary tract, lymphography, myelography, venography, arthrography angiography and DSA.
Product codes
Not Found
Device Description
The Siemens Siregraph CF is a multifunctional, overtable X-ray diagnostic system that was developed for remote examinations. The Siregraph CF has a motorized table tilt from +90° to -18°. The Siregraph CF X-ray tube/spot film system is equipped with a motorized telescoping arm which can be extended to a maximum SID of 150 cm, The x-ray tube/spot film device can be programmed to perform linear tomography (planigraphy) at three different angles; 40° with a tomographic range of 113 cm, 20° with a tomographic range of 131 cm and 8° with a tomographic range of 142 cm. In addition to the overtable tube the Siregraph CF can be configured with an overhead tube support for exposures using Bucky Wall Stand.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
gastrointestinal, cranial, skeletal, thoraic, lung, urinary tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital and clinical environment. The operators of this generator are trained health care professionals familiar with and responsible for the X-ray studies to be performed.
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
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
510(k) SUMMARY
| I. GENERAL INFORMATION: | |
|---|---|
| Establishment: | Siemens Medical Systems, Inc. |
| • Address: | 186 Wood Avenue South |
| Iselin, NJ. 08830 | |
| • Registration Number: | 2240869 |
| • Contact Person: | Kathleen Rutherford |
| Manager, Regulatory Submissions | |
| Telephone: (908) 321- 4779 | |
| TELEFAX: (908) 321 - 4841 | |
| Date of Summary Preparation: | |
| Device Name: | |
| • Trade Name: | Siregraph CF |
| • Common Name: | Remote Multi-functional Overtable |
| X-ray Diagnostic System | |
| • Classification Name: | Image Intensified Fluoroscopic X-ray System |
| • Classification: | Class II |
| Performance Standards: | 21 CFR, Subchapter J |
All system components to which the above standard applies are certified to conform with 21 CFR subchapter J
SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING THE II. SUBSTANTIAL EQUIVALENCE DETERMINATION.
Device Description:
SIEMENS
The Siemens Siregraph CF is a multifunctional, overtable X-ray diagnostic system that was developed for remote examinations. The Siregraph CF has a motorized table tilt from +90° to -18°. The Siregraph CF X-ray tube/spot film system is equipped with a motorized telescoping arm which can be extended to a maximum SID of 150 cm, The x-ray tube/spot film device can be programmed to perform linear tomography (planigraphy) at three different angles; 40° with a tomographic range of 113 cm, 20° with a tomographic range of 131 cm and 8° with a tomographic range of 142 cm. In addition to the overtable tube the Siregraph CF can be configured with an overhead tube support for exposures using Bucky Wall Stand.
Siemens Medical Systems, Inc.
Imaging Systems Group
Ilan
186 Wood Avenue South Iselin, NJ 08830
Tel: (908) 321-4500 Fax: (908) 494-2250
1
SIEMENS
Intended Use:
The Siemens Siregraph CF is a remote overtable radiographic/fluoroscopic x-ray diagnostic system that was designed for universal implementation in the hospital and clinical environment. The Siregraph CF, remote X-ray system, has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoraic and lung exposures as well as examinations of the urinary tract, lymphography, myelography, venography, arthrography angiography and DSA.
Technological Characteristics:
The Siregraph CF is not a stand alone device, but functions as a platform for specific X-ray components (image intensifier, X-ray tube and housing, spotfilm device, Bucky Wall stand, collimator, generator, etc.) and television systems (Videomed DI and Videomed SX) to create a flexible remote radiographic/fluoroscopic x-ray system.
General Safety and Effectiveness Concerns:
Instructions for use are included within the device labeling and the information provided will enable the user to operate the device in a safe and efficacious manner. Several safety features including visual and audible warnings are incorporated into the system design. Furthermore, Siregraph CF is continually monitored, and if an error occurs, the system function will be blocked and an error message displayed. The operators of this generator are trained health care professionals familiar with and responsible for the X-ray studies to be performed. To minimize electrical, mechanical and radiation hazards, Siemens adheres to recognized and established industry practice, and all equipment is subject to final performance testing.
Substantial Equivalence:
The Siregraph CF remote Radiographic / fluoroscopic X-ray diagnostic system for universal implementation in radiographic/fluoroscopic procedures, and the subject of this premarket notification, is substantially equivalent to the following medical devices currently in commercial distribution.
Model
Company
FDA K-Number
Sireskop SX Prestilix 1600X Diagnost 96
Siemens Medical Systems, Inc. GE Medical Systems Philip Medical Systems
Kathleen Rutherford
Kathleen Rutherford Manager, Regulatory Submissions
1/16/96
Date