(90 days)
No
The document describes a standard digital x-ray system and detector, with no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
No
Explanation: This device is described as a "diagnostic radiographic system" used for taking "diagnostic radiographic exposures," indicating its purpose is for diagnosis rather than treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "for taking diagnostic radiographic exposures."
No
The device description clearly outlines multiple hardware components including a tubehead/collimator assembly, U-Arm suspension, generator, generator control, mobile patient table, and digital imaging detector. This is a physical x-ray system, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description: The provided description clearly states that this is a Radiographic System used for taking diagnostic radiographic exposures of various body parts. This involves using X-rays to create images of the internal structures of the body, which is an in vivo (within the body) process.
- Intended Use: The intended use is for taking diagnostic radiographic exposures of patients, not for testing biological samples.
The device is a medical imaging device, specifically an X-ray system, which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
These radiographic systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
Product codes
KPR, MQB
Device Description
This digital diagnostic x-ray system consists of a tubehead/collimator assembly mounted on a U-Arm suspension along with a generator, generator control, and a mobile patient table. Power ratings for the available generators are in the rage of 32 kw to 80 kW. 64 kw is the standard size. Exposure voltage range varies from 40 - 125 KV or 40 - 150 kV with current of 300 - 100 mA. Exposure time is 1 ms - 10s. The system is provided with a digital imaging detector, either the QXR16 or the QXR9 CCD Image Detector and Acquisition Workstation. This device represents the interconnection of two already cleared devices: The X-ray system and the digital detector system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
skull, spinal column, chest, abdomen, extremities, and other body parts.
Indicated Patient Age Range
adult and pediatric subjects
Intended User / Care Setting
qualified/trained doctor or technician
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 results of bench and test laboratory indicates that the new device is as safe and effective as the predicate devices. After analyzing bench and external laboratory testing to applicable standards, it is the conclusion of dxRAD that the DX800 & DX808 Digital Diagnostic Radiographic Systems are as safe and effective as the predicate devices, have few technological differences, and has no new indications for use, thus rendering them substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
NOV - 6 2008
510(k) Summary 510(k) Number K08 dXRAD Solutions Ltd. 1000, 888 3rd Street SW Calgary, AB, Canada T2P 5C5 Phone + 1 403 471 4409 Fax +1403 287 0704 Date Prepared: August 1, 2008 Contact: Darryl Stein, President
P
-
- Identification of the Device: Proprietary-Trade Name: DX800 & DX808 Digital Diagnostic Radiographic Systems Classification Name: Stationary x-ray system, Product Codes KPR and MQB Common/Usual Name: Stationary Digital Diagnostic X-Ray
-
- Indications for Use (intended use) These radiographic systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
-
- Description of the Device: This digital diagnostic x-ray system consists of a tubehead/collimator assembly mounted on a U-Arm suspension along with a generator, generator control, and a mobile patient table. Power ratings for the available generators are in the rage of 32 kw to 80 kW. 64 kw is the standard size. Exposure voltage range varies from 40 - 125 KV or 40 - 150 kV with current of 300 - 100 mA. Exposure time is 1 ms - 10s. The system is provided with a digital imaging detector, either the QXR16 or the QXR9 CCD Image Detector and Acquisition Workstation. This device represents the interconnection of two already cleared devices: The X-ray system and the digital detector system.
-
- Safety and Effectiveness, comparison to predicate device. The results of bench and test laboratory indicates that the new device is as safe and effective as the predicate devices.
Image /page/0/Picture/8 description: The image shows two separate scenes. On the left, a person is depicted carrying a book and a device, possibly a handheld computer or scanner. On the right, there is a computer setup including a monitor, keyboard, mouse, and a computer tower. The image appears to be a black and white print or scan.
1
| Characteristic | Vidar Vision 3000 and Vidar Vision
4000 (K071193). | DX800 & DX808 Digital
Diagnostic Radiographic
Systems |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| Intended Use: | Intended for use by a
qualified/trained doctor or technician
on both adult and pediatric subjects
for taking diagnostic radiographic
exposures of the skull, spinal
column, chest, abdomen, extremities,
and other body parts. Applications
can be performed with the patient
sitting, standing, or lying in the prone
or supine position. | SAME |
| Configuration | Column mount | SAME |
| Performance Standard | 21 CFR 1020.30 | SAME |
| Detectors | 3056 x 3056 (9 megapixels) or 4096
x 4096 (16 megapixels) | SAME |
| Generator | High frequency made by Sedecal | Uses same generator made by
Sedecal |
| Electrical safety | Electrical Safety per IEC-60601. UL
listed | SAME |
6. Substantial Equivalence Chart
7. Conclusion
After analyzing bench and external laboratory testing to applicable standards, it is the conclusion of dxRAD that the DX800 & DX808 Digital Diagnostic Radiographic Systems are as safe and effective as the predicate devices, have few technological differences, and has no new indications for use, thus rendering them substantially equivalent to the predicate devices.
2
Image /page/2/Picture/0 description: The image shows the logo for 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 appears to be a stylized representation of a human figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
dXRAD Solutions Ltd. % Daniel Kamm, P.E. Principal Consultant Kamm & Associates PO Box 7007 DEERFIELD IL 60015
AUG - 9 2013
Re: K082261
Trade/Device Name: DX800 & DX808 Digital Diagnostic Radiographic Systems Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR and MOB Dated: August 4, 2008 Received: September 23, 2008
Dear Mr. Kamm:
This letter corrects our substantially equivalent letter of November 6, 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. Iisting 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
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/ReportalProblem/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/cdrb/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
ndications for Use 510(k) Number (if known): KQ8 2.2 b
Device Name: DX800 & DX808 Digital Diagnostic Radiographic Systems
Indications For Use:
These Radiographic Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic ratiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the pationi sitting, standing, or lying in the prone or supine position.
Prescription Use _X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Usc (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Losm. M. Wher
(Division Sign-Off)
Division of Repro and Radiological De 510(k) Number
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