(29 days)
Not Found
No
The summary describes a standard radiographic imaging system and does not mention any AI or ML capabilities.
No
The device is described as an imaging system used for acquiring radiographic images, which is diagnostic in nature, not therapeutic.
Yes
Explanation: The device is a radiographic imaging system used for acquiring images of anatomical regions, which are then used to diagnose various medical conditions.
No
The device description explicitly details physical hardware components such as a floor-mounted vertical support column, rotating 'C' arm, image receptor, X-ray tube, and collimator, indicating it is a hardware-based system, not software-only.
Based on the provided information, the QV-9000 Universal System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is used for "acquiring radiographic images of various anatomical regions of the human body." This is a description of an in vivo diagnostic imaging system, meaning it is used to image the inside of a living organism.
- Device Description: The description reinforces this by detailing components like an X-ray tube, collimator, and image receptor, all of which are characteristic of an X-ray imaging system used on a patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on samples outside of the body, which are the defining characteristics of an IVD.
Therefore, the QV-9000 Universal System is a radiographic imaging system used for in vivo diagnosis, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The QV-9000 Universal System is a stationary, general purpose, X-ray imaging system used for acquiring radiographic exposures of various parts of the body including the skull, spinal column, chest, thorax, abdomen and extremities. The QV-9000 Universal System is a stationary radiographic system imaging system used for acquiring radiographic images of various anatomical regions of the human body.
Product codes
KPR
Device Description
The QV-9000 Universal System is a stationary, general purpose, X-ray imaging system used for acquiring radiographic exposures of various parts of the body including the skull, spinal column, chest, thorax, abdomen and extremities. The QV-9000 Universal System incorporates a floor-mounted vertical support column, with an attached rotating 'C' arm, an image receptor, an X-ray tube and collimator. The QV-9000 Universal System is compatible for use with either a digital or non-digital (film type) image receptor cabinet.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
various parts of the body including the skull, spinal column, chest, thorax, abdomen and extremities.
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)
This submission is a Special 510(k): Device Modification as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), Quantum Medical Imaging, LLC has provided certification of compliance to 21 CFR 820.30 Design Control requirements, and a description of the internal Risk Analysis procedure. A description and summary of the verificaion and validation testing methods and results utilized to qualify the device modifications is also included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
Special 510(k) Premarket Notification: Device Modificatio QV-9000 Universal System
510(k) Summary
| Trade Name: | QV-9000 Universal System | NOV 2 6 200- |
|---|---|---|
| Sponsor: | Quantum Medical Imaging, LLC | |
| 2002-B Orville Drive North | ||
| Ronkonkoma, NY 11779-7661 | ||
| FDA Registration No. 2438474 | ||
| Device Common Name: | Stationary X-ray System | |
| Classification: | According to Section 513 of the Federal Food, Drug, and | |
| Cosmetic Act, the device classification is Class II. | ||
| Predicate Device: | K023008 -- Quantum Medical Imaging, LLC QV-800 Universal System |
Product Description:
The QV-9000 Universal System is a stationary, general purpose, X-ray imaging system used for acquiring radiographic exposures of various parts of the body including the skull, spinal column, chest, thorax, abdomen and extremities. The QV-9000 Universal System incorporates a floor-mounted vertical support column, with an attached rotating 'C' arm, an image receptor, an X-ray tube and collimator. The QV-9000 Universal System is compatible for use with either a digital or non-digital (film type) image receptor cabinet
Indications for Use:
The QV-9000 Universal System is a stationary radiographic system imaging system used for acquiring radiographic images of various anatomical regions of the human body.
Safety and Performance:
This submission is a Special 510(k): Device Modification as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), Quantum Medical Imaging, LLC has provided certification of compliance to 21 CFR 820.30 Design Control requirements, and a description of the internal Risk Analysis procedure. A description and summary of the verificaion and validation testing methods and results utilized to qualify the device modifications is also included in this submission.
Conclusion:
Based on the indications for use, technological characteristics, performance testing and comparison to predicate device, the proposed Quantum Medical Imaging, LLC QV-9000 Universal System has been shown to be safe and effective for its intended use.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 6 2008
Quantum Medical Imaging, Inc. % Ms. Pamela Papineau, RAC President Delphi Medical Device Consulting, Inc. 5 Whitcomb Avenue AYER MA 01432
Re: K083181
Trade/Device Name: QV-9000 Universal System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: October 24, 2008 Received: October 28, 2008
Dear Ms. Papineau:
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 either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
2
Page 2
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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
hoque In thang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Quantum Medical Imaging, LLC October 24, 2008
Special 510(k) Premarket Notification: Device Modification QV-9000 Universal System
Page 1 of 1
510(k) Number (if known): K083181
Device Name: _ QV-9000 Universal System
Indications for Use:
The QV-9000 Universal System is a stationary radiographic imaging system used for acquiring radiographic images of various anatomical regions of the human body.
Prescription Use X (Per 21 CFR 801 Subpart D)
Over-the -Counter Use (Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Amri M. Khany
(Division Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number
01 16