(35 days)
Not Found
No
The document describes a digital imaging system for acquiring, recording, and displaying radiographic images. It mentions image processing but does not mention AI, DNN, or ML, nor does it provide details about training or test sets typically associated with AI/ML development.
No
The device is used to acquire, record, and display radiographic images for diagnostic purposes, not to treat or alleviate a disease or condition.
No
The device is described as an image acquisition, recording, and display system for radiographic images. It helps healthcare professionals acquire images, but it does not interpret or analyze those images to make a diagnosis itself.
No
The device description explicitly states it is a "PC-based, 10 bit acquisition digital imaging system" and an "optional integral component of a radiographic/fluoroscopic x-ray system," indicating it includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Fluorospot Compact is a digital imaging system for acquiring, recording, and displaying radiographic images from an x-ray system. It is used for imaging procedures involving contrast medium, urological examinations, and vascular/non-vascular procedures.
- Device Description: The description reinforces that it's a PC-based digital imaging system for use with x-ray systems.
- Nature of IVDs: 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. This device does not perform any such tests on biological samples. It is an imaging system that visualizes internal structures using x-rays.
Therefore, the Fluorospot Compact falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Fluorospot Compact digital imaging system, is an optional integral component of a radiographic/fluoroscopic x-ray system, and as such it is not considered a stand alone device. The Fluorospot Compact is intended for use with x-ray systems to digitally acquire, record and display radiographic images. The Fluorospot Compact enables the trained healthcare professional to consistently acquire high quality images for fluoroscopic examinations with contrast medium, urological examinations as well as vascular and non-vascular procedures.
Product codes (comma separated list FDA assigned to the subject device)
90JAA
Device Description
The Fluorospot Compact is a PC-based, 10 bit acquisition digital imaging system where images are acquired in 1024^2 format. It can be configured with conventional overtable/under-table x-ray systems (e.g. commercially available Sireskop SX and Siregraph CX). Configuring the conventional systems with Fluorospot Compact provides the systems with multi-functional use capability, thus allowing trained healthcare professionals to perform x-ray imaging using conventional film or digital imaging. Upon acquiring digital images, the user can display them on the live monitor in the exam room, as well as the control room for review. Multiple digital image acquisition and storage is possible without interrupting the procedure to change film.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopic X-ray; radiographic/fluoroscopic x-ray
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained healthcare professional
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
SIEMENS
APPENDIX 1
JUL 1 4 1998
510(k) Summary Fluorospot Compact
Submitted by:
Siemens Medical Systems, Inc. 186 Wood Avenue South Iselin, NJ 08830
June 8, 1998
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
1. Contact Person:
Ms. Malgorzata Stanek Phone: (732)321-3950 Fax: (732)321-4841
Device Name and Classification: 2.
Trade Name: Classification Name: CFR Section: Device Code:
Fluorospot Compact Image Intensified Fluoroscopic X-ray System 21 CFR 8892.1650. Class II 90JAA
" "
3. Substantial Equivalence:
The Fluorospot Compact is substantially equivalent to the following Siemens Medical Systems' devices:
-
- Fluorospot T.O.P K961871, cleared by FDA on July 31, 1996
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- Fluorospot H (Version 2) K914525, cleared by FDA on November 19, 1991
Fluorospot H (Version 1) K911082, cleared by FDA on May 1, 1991
4. Device Description:
The Fluorospot Compact is a PC-based, 10 bit acquisition digital imaging system where images are acquired in 10242 format. It can be configured with conventional overtable/under-table x-ray systems (e.g. commercially available Sireskop SX and Siregraph CX). Configuring the conventional systems with Fluorospot Compact provides the
Siemens Medical Systems, Inc.
Sales and Service
್ಕ
1
SIEMENS
systems with multi-functional use capability, thus allowing trained healthcare professionals to perform x-ray imaging using conventional film or digital imaging. Upon acquiring digital images, the user can display them on the live monitor in the exam room, as well as the control room for review. Multiple digital image acquisition and storage is possible without interrupting the procedure to change film.
న. Intended Use of the Device:
The Fluorospot Compact digital imaging system, is an optional integral component of a radiographic/fluoroscopic x-ray system, and as such it is not considered a stand alone device. The Fluorospot Compact is intended for use with x-ray systems to digitally acquire, record and display radiographic images. The Fluorospot Compact enables the trained healthcare professional to consistently acquire high quality images for fluoroscopic examinations with contrast medium, urological examinations as well as vascular and non-vascular procedures.
Summary of Technological Characteristics of the Device Compared to the Predicate 6. Device:
The Fluorospot Compact has the same technological characteristics as the predicates Fluorospot T.O.P. and Fluorospot H. They utilize PC based technology to acquire, store and post process images from the image intensifier/TV chain output of an image intensified fluoroscopic system.
Kathleen Rutherford
Kathleen Rutherford Manager, Regulatory Submissions Siemens Medical Systems, Inc.
Siemens Medical Systems, Inc.
Sales and Service
186 Wood Avenue South Iselin, NJ 08830
Tel: (732) 321-4500 Fax: (732) 494-2250
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with three lines representing its head and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 4 1998
Malgorzata Stanek Siemens Medical Systems, Inc. 186 Wood Avenue South Iselin, NJ 08830
Re:
Fluorospot Compact Dated: June 8, 1998 Received: June 9, 1998 Regulatory class: II 21 CFR 892.1650/Procode: 90 JAA
Dear Mr. Stanek:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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, against misbranding and adulteration.
If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Resulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (2) CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication 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 Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrb/dsmaldsmamain.html".
Sincerely yours,
Kilian Yih
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
APPENDIX 2
INDICATIONS FOR USE
510(k) Number (if known): Fluorospot Compact Device Name:
Indications For Use:
The Fluorospot Compact digital imaging system, is an optional integral component of a radiographic/fluoroscopic x-ray system, as such it is not considered a stand alone device. The Fluorospot Compact is intended for use with x-ray systems to digitally acquire, record and display radiographic images. The Fluorospot Compact enables the trained healthcare professional to consistently acquire high quality images for fluoroscopic examinations with contrast medium, urological examinations as well as vascular and non-vascular procedures.
( please do no write below this line- continue on another page if needed )
Concurrence of the CDRH, Office of Device Evaluation (ODE) .
・・・・
David A. Ingram
(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Devic
510(k) Number K982028
V Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109)