(111 days)
Not Found
No
The description focuses on image joining based on operator input, with no mention of AI/ML terms or functionalities.
No
The device is described as generating radiographic images, which is diagnostic, not therapeutic. Its purpose is to create images of human anatomy, not to treat a condition.
No
The device is used to generate radiographic images, which are then interpreted by a radiologist. It acts as an image acquisition and processing tool, not a device that directly provides a diagnosis or diagnostic information based on analysis of the images.
No
The device description explicitly states it is an "Image Pasting Application for Revolution XR/d Digital Radiographic Imaging System," indicating it is software that operates with a specific hardware system (the Revolution XR/d). The performance studies also mention evaluation for electrical, mechanical, and radiation safety, which are characteristics of hardware, not standalone software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The description clearly states the device is an "Image Pasting Application for Revolution XR/d Digital Radiographic Imaging System" and is used for "generating radiographic images of human anatomy" and "electronically join[ing] them to create a single electronic image."
- Input: The input is "Radiographic" images, which are generated by external radiation passing through the body, not by analyzing bodily specimens.
- Output: The output is a combined radiographic image, not a diagnostic result derived from analyzing a biological sample.
The device is a software application that processes and combines radiographic images, which falls under the category of medical imaging software, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Image Pasting Application for Revolution XR/d Digital Radiographic Imaging System is indicated for use in generating radiographic images of human anatomy. This device is not intended for mammographic applications.
Product codes
MOB
Device Description
Image pasting allows the operator to generate 2 to 5 sequential radiographic images and electronically join them to create a single electronic mage.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
radiographic
Anatomical Site
human anatomy
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
The device has been evaluated for electrical, mechanical, and radiation safety, and conforms with applicable medical device standards through an Internationally Recognized Test Laboratory. Clinical Tests: None required.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.
0
JAN 1 3 2005
Special 510(k) Premarket Notification GE Medical Systems - Image Pasting
Attachment B:
Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92(c).
Image /page/0/Picture/5 description: This document appears to be a submission form for GE Medical Systems. It includes the submitter's information, which is GE Medical Systems located in Milwaukee, WI. The contact person is Mark M Stauffer, who works in Safety and Regulatory Engineering, and their phone and fax numbers are listed. The document also mentions the device name, which is an image pasting application for the Revolution XR/d Digital Radiographic Imaging System, and the marketed device, which is the Revolution XR/d Digital Radiographic Imaging System with the 510(k) Number K012389.
Device Description: Image pasting allows the operator to generate 2 to 5 sequential radiographic images and electronically join them to create a single electronic mage.
Indications for Use: The Revolution XRVd is intended for use in generating radiographic Images of human anatomy. It is not intended for mammographic use.
Comparison with Predicate Device: Revolution XR/d and Revolution XR/d with image pasting application are used to generate radiographic invol and revolution XFU with image pasting application date digitally of at the users preference, on film. Each device has one solid state x-ray detector in the cabino x-adiation On occasion a sadiologic in thin. The detectors have a 41 cm by 41 cm surface for capturing x-radiation. On occasion a ratiologist desires a radiograph covering an area larger than that of the delector. Using Revolution XRVd (or any andographic system) and of the of the of
over oversized film Revolution XRVd (or any andiographic system) the techn oversized film cassette, on with either one wide-angle or several smaller overlapping exposures will be made. Using Revolution on the one one the technician will be able to make several digital exposures and electronically join them together for viewing as a single, longer radiograph.
The composition of the two systems is nearly identical. Modifications are made to Revolution XFVd to end of the more of the wo wo works to houly luential. Mounce to Revolune and
Summany of Studies: The device has been evaluated for electrical, mechanical, and radiation safety, and conforms with applicable medical of thecated for thechanical, micrlancal, and radionally Recognized Test Laboratory.
Clinical Tests: None required.
Conclusion: Intended uses and other key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination. Mended uses and fundamental scientific technology are the same as the legally market Revolution XRd Radiographic Imaging System. The 13485 and development process of the manufacturer conforms with 21 CFR 820, ISO 9001 and ISO 13485 quality systems. The device conforms to applicable medical device safety standards and compliance is verifled through independent evaluation with factory surveillance. Therefore, it is the opinion of GE Modical Systems that the modified medical device is substantially equivalent with respect to sthe and effectiveness to devices currently cleared for market including Revolution XRVd.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Mark M. Stauffer Safety and Regulatory Engineer Diagnostic X-ray Engineering GE Medical Systems LLC P.O. Box 414 MILWAUKEE WI 53188
AUG 2 3 2013
Re: K042602
Trade/Device Name: Revolution XR/d Digital Radiographic X-Ray Systems Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: December 16. 2004 Received: December 17. 2004
Dear Mr. Stauffer:
This letter corrects our substantially equivalent letter of January 13, 2005.
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
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Page 2
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 nredicate 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
3
Special 510(k) Premarket Notification GE Medical Systems - Image Pasting
STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known):
Device Name: Image Pasting Application for Revolution XR/d Digital Radiographic Imaging System
Indications for Use
Image Pasting Application for Revolution XR/d Digital Radiographic Imaging System is indicated for use in generating radiographic images of human anatomy. This device is not intended for mammographic applications.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801-109)
OR Over-The-Counter Use_
Daniel A. Simon
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devic
510(k) Number K042602