(92 days)
Not Found
Not Found
No
The summary describes modifications to mechanical components (positioner and compressor) of an existing X-ray system and does not mention any AI or ML related terms or functionalities.
No
Explanation: The device is an X-ray system used for imaging procedures (radiography, fluoroscopy, interventional, and angiography), not for treating or curing a disease or condition.
Yes
Explanation: The device is indicated for performing "general R&F, radiography, fluoroscopy, interventional and angiography procedures/applications," which are all diagnostic imaging procedures used to aid in disease detection or patient assessment.
No
The device description explicitly states it is an "Analog X-ray System and PRECISION RXi Digital X-ray System" and describes "design changes including modifications to the positioner tilting/elevating movement and the compressor," which are hardware components.
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 system is for performing general R&F, radiography, fluoroscopy, interventional, and angiography procedures/applications. These are all in vivo procedures, meaning they are performed on a living organism (the patient).
- Device Description: The description mentions an X-ray system and modifications to its physical components (positioner, compressor). This aligns with an imaging device used on a patient.
- Input Imaging Modality: The input modality is X-ray, which is used for imaging the inside of a patient's body.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), which is the defining characteristic of an IVD.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic purposes. This device is used to image the human body directly.
N/A
Intended Use / Indications for Use
The PRECISION RXi Analog X-ray System and PRECISION RXi Digital X-ray System are indicated for performing general R&F, radiography, fluoroscopy, interventional and angiography procedures/applications.
Product codes (comma separated list FDA assigned to the subject device)
OW2, JAR, I21 (from page 1)
OWB, JAA, IZI (from page 3)
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Not Found
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.
Not Found
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
Food & Drug Administration PRECISION RXi System Simplified 510(k) August 6, 2008
Name and Address of Sponsor
GENERAL MEDICAL MERATE S.p.A. Via Partigiani, 25 24068 SERIATE (BG) ITALIA Telephone: +39 035 299537 Fax: +39 035 297787
Establishment Registration Numbers
8020997
Name and Address of Official Correspondent
Regulatory Insight, Inc. 5401 S. Cottonwood Ct. Greenwood Village, Colorado 80121 Contact: Mr. Kevin Walls, RAC Telephone: 720-962-5412 Fax: 720-962-5413 Email: kevin@reginsight.com
Truth and Accuracy Statement
Refer to Appendix A.
510(k) Statement
Refer to Appendix B.
Device Name
Proprietary Name: Precision RXi Analog X-ray System and PRECISION RXi Digital Xray System
Common Name: Image-intensified fluoroscopic x-ray system, Solid state x-ray imager (flat panel/digital imager).
Classification Name: Image-intensified fluoroscopic x-ray system, Solid state x-ray imager (flat panel/digital imager).
Classification, Panel and Product Code
Class II, Radiology, OW2, JAR, 121
Previous Submission
The PRECISION RXi System was originally cleared by the FDA under 510(k) K041605
Page 1
1
Food & Drug Administration PRECISION RXi System Simplified 510(k) August 6, 2008
Indications for Use
The PRECISION RXi Analog X-ray System and PRECISION RXi Digital X-ray System are indicated for performing general R&F, radiography, fluoroscopy, interventional and angiography procedures/applications.
Please refer to the separate Indications for Use Statement contained in Appendix C,
Description of Design Changes
Intelligent Tilting
Positioner tilting / elevating movement will be modified as follows:
- When the table top is longitudinally moved, the tilting command should also drive 1 table top longitudinal movement to drive it back to center before tilting.
- 2 To ease scanning, when the tube is at the end of travel, continuing to push the tube joystick should drive longitudinal movement of the table top (at the current speed of table top).
- ന When the positioner gets in interdiction movement (due to room constraints such as low ceiling), enable SID automatic movement back when table is tilted back to horizontal position (this shall be possible after stop of tilting movement and consequent movement back of SID).
- ব When 16" I.I. is elevated and table top moved down (below 60mm) and command for cassette out is pushed, enable automatic elevating movement and only when enough room for I.I. movement down is created, the cassette out movement will be activated.
Compressor
This modification frees the patient from the compressor by means of a simple lever and a minimum effort by the operator when the Unit is in power OFF and the compressor is on the patient.
2
Image /page/2/Picture/0 description: The image shows the logo of the Department of Health & Human Services. The logo consists of 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 logo is in blue.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
General Medical Merate S.P.A. % Kevin Walls, RAC Principal Consultant Regulatory Insight, Inc. 5401 S. Cottonwood Court GREENWOOD VILLAGE CO 80121
JUL 30 2012
Re: K082243
Trade/Device Name: PRECISION RXi Analog X-ray System and PRECISION RXi Digital X-ray System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, JAA and IZI Dated: August 6. 2008 Received: August 11, 2008
Dear Mr. Walls:
This letter corrects our substantially equivalent letter of November 7, 2008.
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 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
Indications for Use
510(k) Number (if known): _KD & 2243
Device Name:
Indications for Use: The PRECISION RXi Analog X-ray System and PRECISION RXi Digital X-ray System are indicated for performing general R&F, radiography, fluoroscopy, interventional and angiography procedures/applications.
Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Heidi Reimer
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number.
Page 1 of 1