(52 days)
Not Found
No
The summary describes a standard fluoroscopic X-ray system and does not mention any AI or ML capabilities, image processing features that might imply AI/ML, or details about training/test data sets which are typical for AI/ML devices.
No
The device is described as an X-ray diagnostic system, used to visualize anatomical structures for diagnostic purposes rather than for treating a condition.
Yes
The "Device Description" explicitly states, "Siregraph T.O.P. is a universal fluoroscopic X-ray diagnostic system."
No
The device description clearly states it is a "universal fluoroscopic X-ray diagnostic system with an overtable X-ray tube assembly," indicating it is a hardware system that utilizes X-rays to create images.
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 Siregraph T.O.P. systems are described as X-ray systems that visualize anatomical structures by converting X-rays into visible images. This is an in vivo process, meaning it is performed on a living organism.
- Intended Use: The intended use clearly states the visualization of anatomical structures and lists various medical applications that involve imaging the inside of the body.
Therefore, the function and intended use of the Siregraph T.O.P. systems fall under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Siregraph T.O.P. 33 and T.O.P. 40 Universal Fluoroscopic X-ray Systems are devices intended to visualize anatomical structures by converting a pattern of X-ray into a visible image through electronic amplification. Both systems have medical applications ranging from examination of the urogenital tract, gastrointestinal exposures as well as lymphography, endoscopy, myelography, venography, pediatrics, arthrography, interventional radiology, digital angiography, and digital angiography (DSA).
Indications for Use:
The Siregraph T.O.P. 33 and Siregraph T.O.P. 40 Universal Fluoroscopic X-ray Systems are devices intended to visualize anatomical structures by converting a pattern of X-ray into a visible image through electronic amplification. Both systems have medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as and examination of the urogenital tract, lymphography, venography, pediatrics, arthrography, interventional radiology, digital angiography, and digital subtraction angiography (DSA).
Product codes (comma separated list FDA assigned to the subject device)
90JAA, 0WB
Device Description
Siregraph T.O.P. is a universal fluoroscopic X-ray diagnostic system with an overtable X-ray tube. Two versions are available: Siregraph T.O.P. 33 for use with an undertable spot film device, and Siregraph T.O.P. 40 for use in Digital Angiography. Both systems are operated either via the undertable image intensifier or a remote control console.
The Siregraph T.O.P. has the same technological characteristics as the predicate Siregraph D3/D340. Both systems are remote fluoroscopic X-ray diagnostic systems with an overtable X-ray tube and undertable assembly. Like Siregraph D3 and D340, Siregraph T.O.P. consists of the basic system and standard system components: X-ray generator, X-ray tube, image intensifier, TV system, digital imaging system, patient support table, and optional ceiling support for the X-ray tube.
The differences between Siregraph D3/D340 and Siregraph T.O.P. are:
- The Siregraph T.O.P. basic system is redesigned for better ergonomics.
- The communication network among system components (e.g., generator and table) of the XCS communication system is employed.
- Siregraph T.O.P. are configured with the latest commercially available system components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Urogenital tract, gastrointestinal, cranial, skeletal, thoracic, lung
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
APR 2 1 1997
SIEMENS
Attachment 12
510(k) Summary
Siregraph T.O.P. 33 and Siregraph T.O.P. 40
Submitted by:
Siemens Medical Systems, Inc. 186 Wood Avenue South Iselin, NJ 08830
February 27, 1997
This 510(k) summary of safety and effectiveness information is being This 510(k) summary of safety and effectiveness indomitation is only of the first of SMDA 1990 and 21 CFR 8807.92.
- Contact Person: 1. Ms. Jing Zhang Fax: (908)321-4841 Phone: (908)321-4927
Device Name and Classification: cation:
Siregraph T.O.P. 33 and Siregraph T.O.P. 40 2. Trade Name: Siregraph 1.O.I . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Universal Fluoroscopic X 16, 27-14, 10-12-2014
Image Intensified Fluoroscopic X-ray System Classification Name: Radiology Classification Panel: 21 CFR 5892.1650 CFR Section: Class II Device Class: 90JAA | 0WB Device Code:
Intended Use: 3.
Intended Use:
The Siregraph T.O.P. 33 and T.O.P. 40 Universal Fluoroscopic X-ray
The Siregraph T.O.P. intended to visualize anatomical structures by The Siregraph T.O.P. 33 and 1.O.r. 40 Director Frases on Systems ag a pattern of X-ray into a visible image through electronic
converting a pattern of X-ray into a visible image through electronic amplification. Both systems have medical applications ranging from amplification. Both systems have mechear applications of the one of the one of the one of the one of the progenital tract, gastrointestinal examination of the unogenital tract, exposures as well as examination of the urogeraphy, pediatrics,
lymphography, endoscopy, myelography, venography, pediatrics, Shport
lymphography, endoscopy, myelography, venography, pediation, and digital
arthrography, interventional radiology, digital angiography, and digital
e and digital and sou arthrography angiography (DSA).
- Substantial Equivalence: Substantial Equivalence:
The Siregraph T.O.P. 33 and 40 are substantially equivalent to the
The Siregraph in the secomercial distribution: 4. The Siregraph T.O.I : 55 and 10 and 10 and 10 and
1
SIEMENS
- Siregraph D3 and D340, K860913 . ● Siemens Medical Systems, Inc.
- Siregraph CF, K960266 . Siemens Medical Systems, Inc.
Device Description: 5.
Device Description:
Siregraph T.O.P. is a universal fluoroscopic X-ray diagnostic system Siregraph T.O.F. Is a univelsar newslone Two versions are available: with an overtable X-ray tube ussement on dertable spot film device, and Siregraph T.O.P. 35 for use will uit all clices on one are operated either via Siregraph 1.O.P. 40 for use in Digital Hasse and operated either via undertable image antene remote control console.
-
Summary of Technological Characteristics of the Device Compared to 6. the Predicate Devices:
the Predicate Devices.
Siregraph T.O.P. has the same technological characteristics as the Siregraph D3/D340. Both systems are remote fluoroscopic Xpredicate Siregraph D57 D540. Doctor Doct able assembly. Like ray diagnostic systems with and on onsists of the basic system Siregraph DS and DS40, Stregraph and standard system components: X-ray (patient support table), and slattensifier, TV system, digital imaging generator, A-ray tube, intage interestions. In and optional ceilingsystem, inontors, optional a X-ray tube. The differences between Siregraph D3/D340 and Siregraph T.O.P. are: -
The Siregraph T.O.P. basic system is redesigned for better . ergonomics.
-
The communication network among system components (e.g., . The communication network antong of the XCS communication system is employed.
-
Siregraph T.O.P. are configured with the latest commercially . available system components.
Kathleen Rutherford
Kathleen Rutherford Manager, Regulatory Submissions Siemens Medical Systems, Inc.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing-like shapes extending upwards and to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Ms. Kathleen Rutherford Manager, Regulatory Submissions Siemens Medical Systems, Inc. 186 Wood Avenue South ISELIN NJ 08830
FEB 1 9 2013
Re: K970734
Trade/Device Name: Siregraph T.O.P. 33 and Siregraph T.O.P 40 Universal Fluoroscopic X-ray System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB and JAA Dated: February 27, 1997 Received: February 28, 1997
Dear Ms. Rutherford:
This letter corrects our substantially equivalent letter of April 21, 1997.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of
3
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Attachment 1
Indications for Use
510(k) Number (if known): __ K 9 7 0 7 3 4
Device Name: Siregraph T.Q.P. 33 and Siregraph T.Q.P. 40
Indications for Use:
The Siregraph T.O.P. 33 and Siregraph T.O.P. 40 Universal Fluoroscopic X-ray
Press of the Sirest of the closed to risualize, anatomical structures by converting The Siregraph T.O.P. 33 and Siregraph 1.O.P. 40 Onvertures by converting
Systems are devices intended to visualize anatomical structures by converting Systems are devices intended to visible image through electronic and infraction. Both
a pattern of X-ray into a visible image through electronic assistentinal a pattern of X-ray into a vision into intough trom gastrointestinal
systems have medical applications ranging from gastrointes as v systems have medical applications from gastronomics as well as
examinations to cranial, skeletal, thoracic and lung exposures as well as examinations to cranial, skeletal, thoracte and iding exposures as well as and examination of the urogenital tract, iyniphography, eraciology, digital
venography, pediatrics, arthrography, interventional radiology, digital venography, pediatrics, arthrography,
angiography, and digital subtraction angiography (DSA).
Concurrence of the CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K970734 |
| Prescription Use | ✓ | OR | Over-The-Counter Use | |
|---|---|---|---|---|
| (per 21 CFR 801.109) |
Pg. 6 of 58