(21 days)
Not Found
No
The summary describes automated features like image pasting and autopositioning, but does not mention AI, ML, deep learning, or any related concepts. The description focuses on workflow improvements and electronic image joining, which are typically achieved through conventional programming and image processing techniques.
No
The device is indicated for generating radiographic images for diagnostic purposes, not for treating any medical conditions.
Yes
The device generates radiographic images of human anatomy, which are used by healthcare professionals to diagnose medical conditions. Imaging systems are considered diagnostic devices.
No
The device description explicitly states it is a "digital radiographic x-ray system," which 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 the device is for "generating radiographic images of human anatomy." This is an in-vivo imaging process, meaning it involves imaging the body directly, not analyzing samples taken from the body.
- Device Description: The description reinforces that it's a "digital radiographic x-ray system," which is used for in-vivo imaging.
- No mention of biological samples: There is no mention of analyzing blood, urine, tissue, or any other biological samples, which is a core characteristic of IVD devices.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic purposes. This device is an imaging system used to visualize internal structures of the body directly.
N/A
Intended Use / Indications for Use
The Revolution XR/d is intended for use in generating radiographic images of human anatomy. It is not intended for mammographic use.
Revolution XR/d Digital Radiographic Imaging System with Image Pasting and Autopositioning is indicated for use in generating radiographic images of human anatomy. This device is not intended for mammographic applications.
Product codes (comma separated list FDA assigned to the subject device)
90 KPR, 90 MQB
KPR, MOB
Device Description
The Revolution XR/d with Image Pasting and Autopositioning is the latest version of the Revolution XR/d digital radiographic x-ray system. It includes features and functions that have been developed since the introduction of the original XRd in 2001. Auto image pasting enables the operator to electronically join several sequentially acquired radiographs into a single image (such as spine images). Autopositioning offers improved end user workflow by minimizing the number of steps needed to set up and initiate imaging.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The device has been evaluated for electrical, and radiation safety, and conforms to applicable medical device safety standards, as conlirmed by a Nationally Recognized Test Laboratory.
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
§ 892.1680 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
2005 APR 8
Attachment B:
Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92(c).
KOSOTOU
GE Medical Systems
General Electric Company P.O. Box 414, Milwaukee, WI 53201
| Submitter: | GE Medical Systems
PO Box 414
Milwaukee, WI 53201 |
|------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | John L. Schmidt
Safety and Regulatory Engineering
Telephone: 262-548-4964; Fax: 262-544-3863 |
| Date Prepared: | March 15, 2005 |
| Device Name: | Revolution XR/d Digital Radiographic Imaging System with Image Pasting and
Autopositioning
21 CFR 892.1680 and 892.1650; 90 KPR and 90 MQB |
| Marketed Device: | Revolution XR/d Digital Radiographic Imaging System, 510(k) Number K012389
Image Pasting Application, K042602, currently in commercial distribution. |
Device Description: The Revolution XR/d with Image Pasting and Autopositioning is the latest version of the Revolution XR/d digital radiographic x-ray system. It includes features and functions that have been developed since the introduction of the original XRd in 2001. Auto image pasting enables the operator to electronically join several sequentially acquired radiographs into a single image (such as spine images). Autopositioning offers improved end user workflow by minimizing the number of steps needed to set up
and initiate imaging.
Indications for Use: The Revolution XR/d 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 with image pasting and autopositioning is substantially equivalent to the predicate Revolution XR/d, with image pasting application option. The features and functions available on the new version XR/d offer improved workflow and ease-of-use to the operator, but do not alter the intended use of the device.
Summary of Studies: The device has been evaluated for electrical, and radiation safety, and conforms to applicable medical device safety standards, as conlirmed by a Nationally 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. Intended uses and fundamental scientific technology are the same as the legally marketed Revolution XR/d Radiographic Imaging System with Image Pasting Application. The design and development process of the manufacturer conforms to 21 CFR 820, ISO 9001 and ISO 13485 quality systems. The device conforms to applicable medical device safety standards and compliance is verified through independent evaluation with factory surveillance. Therefore, it is the opinion of GE Medical Systems that the modified medical device is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market including Revolution XR/d.
1
Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo consists of two parts: a symbol on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The symbol is a stylized representation of a human figure, and the text is written in a clear, sans-serif font. The color of the logo is a light blue.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. John L. Schmidt Safety and Regulatory Engineer General Electric Co. GE Medical Systems LLC PO Box 414 MILWAUKEE WI 53201
AUG - 9 2013
Re: K050704
Trade/Device Name: Revolution XR/D Digital Radiographic Imaging System With Image Pasting Autopositioning
Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR and MOB Dated: March 16, 2005 Received: March 18. 2005
Dear Mr. Schmidt:
This letter corrects our substantially equivalent letter of April 8, 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. Drue, 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
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 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
3
Special 510(k) Premarket Notification GE Medical Systems - XR/d with Image Pasting and Autopositioning
STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known): __ Ko 50704_________________________________________________________________________________________________________________________________________
Device Name: Revolution XR/d Digital Radiographic Imaging System with Image Pasting and Autopositioning
Indications for Use
Revolution XR/d Digital Radiographic Imaging System with Image Pasting and Autopositioning 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_
Nancy C. Croston
(Division Sign-Off)
Division of Reproductive. Abde area Carloning al Devices ் ! O(K) Number