(163 days)
Not Found
No
The summary describes a standard digital imaging system for radiographic images, focusing on acquisition, processing, storage, display, and distribution. There is no mention of AI, ML, or related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML algorithms.
No
The device is described as a digital imaging system intended for the capture and display of radiographic images for diagnostic purposes, not for treating any medical condition.
Yes
The device is described as "a digital imaging system intended for the capture and display of radiographic images of human anatomy, as part of a diagnostic x-ray system" and its intended use includes "diagnostic x-ray system."
No
The device description explicitly states that CPI RAD VISION is a "component of a complete radiographic x-ray system" and mentions an "optional hardware interface". This indicates it is not solely software.
Based on the provided information, the CPI RAD VISION 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, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- CPI RAD VISION Function: The CPI RAD VISION is a digital imaging system that captures and displays radiographic images of human anatomy using X-rays. This is a form of in vivo (within the body) imaging.
- Intended Use: The intended use clearly states it's for capturing and displaying radiographic images as part of a diagnostic x-ray system, not for testing biological specimens.
- Device Description: The description focuses on controlling digital imaging functions and potentially X-ray generator functions, all related to generating and processing X-ray images of the body.
Therefore, the CPI RAD VISION falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
CPI RAD VISION is a digital imaging system intended for the capture and display of radiographic images of human anatomy, as part of a diagnostic x-ray system. It is intended for use in general radiographic examinations and applications. The device is not intended for mammographic, fluoroscopic or angiographic applications.
Product codes (comma separated list FDA assigned to the subject device)
MQB, KPR
Device Description
The CPI RAD VISION product will provide a user interface to control the digital imaging functions of a radiographic acquisition modality (acquisition, processing, storage, display, and distribution of images from a Solid State X-ray Imager (SSXI)).
The CPI RAD VISION product will also provide either an option on the user interface to control the x-ray generator functions required by a radiographic acquisition modality or an optional hardware interface to allow the x-ray generator functions to be controlled by an independent third-party operator console while maintaining synchronization with the digital imaging functions of the product.
CPI RAD VISION is a component of a complete radiographic x-ray system.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
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)
A comprehensive Electrical safety (IEC60601-1:2005) and Electromagnetic compatibility (IEC60601-1-2, Edition 3:2007-03), Software verification (IEC60601-1-4:2000), other performance testing and the acquisition of sample clinical images were performed on CPI RAD VISION product which demonstrated that CPI RAD VISION is safe and effective, and is equivalent to the aforementioned predicates devices.
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
Image /page/0/Picture/1 description: The image shows the logo for Communications & Power Industries. The logo is black and white and features the letters "CPI" in a stylized font. The words "Communications & Power Industries" are written in a smaller font below the letters. The logo is simple and modern.
FEB 1 5 2013
e
510(k) Summary
Prepared in accordance with 21 CFR 807.92(c)
Date Prepared:
December 19, 2012
Name of Contact Person: Norm Morikawa
| Address: | Communications & Power Industries Canada Inc.
45 River Drive, Georgetown, Ontario, L7G 2J4, Canada |
|----------------------|-------------------------------------------------------------------------------------------------------|
| Telephone: | 905-877-0161 |
| Fax: | 905-877-5327 |
| Device Trade Name: | CPI RAD VISION |
| Common Name: | Digital Radiography |
| Classification Name: | Stationary x-ray system (21 CFR 892.1680, Product Code
MQB). |
Device Description:
The CPI RAD VISION product will provide a user interface to control the digital imaging functions of a radiographic acquisition modality (acquisition, processing, storage, display, and distribution of images from a Solid State X-ray Imager (SSXI)).
The CPI RAD VISION product will also provide either an option on the user interface to control the x-ray generator functions required by a radiographic acquisition modality or an optional hardware interface to allow the x-ray generator functions to be controlled by an independent third-party operator console while maintaining synchronization with the digital imaging functions of the product.
CPI RAD VISION is a component of a complete radiographic x-ray system.
Intended Use:
CPI RAD VISION is a digital imaging system intended for the capture and display of radiographic images of human anatomy, as part of a diagnostic x-ray system. It is intended for use in general radiographic examinations and applications. The device is not intended for mammographic, fluoroscopic or angiographic applications.
1
Image /page/1/Picture/0 description: The image shows the logo for Communications & Power Industries. The logo consists of the letters CPI in a stylized font, with the words "Communications & Power Industries" written below it. Below that is the text "Communications & Power Industries Canada Inc."
Comparison to substantially equivalent devices:
The CPI RAD VISION product is substantially equivalent to the Carestream DRX-1 System (K090318) and the InfiMed is Digital X-ray Imaging System (K093066) since it shares the same intended use, major components, technology, and standard features as these two predicate devices. The following table depicts the comparison characteristics:
| | CPI RAD
VISION | Carestream
DRX-1
System | i 5 Digital X-
ray Imaging
System |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|-------------------------------|------------------------------------------------|
| Indicated for use in general radiographic
examinations and applications. Not intended
for mammographic, fluoroscopic or
angiographic applications. | ✓ | ✓ | ✓ |
| Components / Technology | | | |
| High-performance desktop Computer
Workstation, large-area LCD Display
Monitor, Software | ✓ | ✓ | ✓ |
| High-resolution Solid State X-ray Imager | ✓ | ✓ | ✓ |
| Interface for non-integrated configuration,
based on a modern circuit board with
standard electrical I/O. | ✓
(optional) | ✓ | ✓
(optional) |
| Medical Grade Isolation Transformer | ✓ | x | x |
| Features | | | |
| Radiographic image acquisition from Solid
State X-ray Imagers. | ✓ | ✓ | ✓ |
| Enhancement, display, manipulation, review
and distribution of radiographic images. | ✓ | ✓ | ✓ |
| Work list for patient scheduling. | ✓ | ✓ | ✓ |
| Option for user to manage x-ray settings | ✓ | x | ✓ |
Performance Testing:
A comprehensive Electrical safety (IEC60601-1:2005) and Electromagnetic compatibility (IEC60601-1-2, Edition 3:2007-03), Software verification (IEC60601-1-4:2000), other performance testing and the acquisition of sample clinical images were performed on CPI RAD VISION product which demonstrated that CPI RAD VISION is safe and effective, and is equivalent to the aforementioned predicates devices.
2
Image /page/2/Picture/0 description: The image shows the logo for Communications & Power Industries Canada Inc. The logo consists of the letters "CPI" in a stylized font, with the words "Communications & Power Industries" written below it. The words "Communications & Power Industries Canada Inc." are written below that. The logo is black and white.
Conclusion:
The Performance Data demonstrate that CPI RAD VISION product is safe and effective as the predicate devices. Based on the information in this submission, similarity to the predicates devices, and the acquisition of sample clinical images, it is the opinion of CPI (Communications & Power Industries) Canada Inc. that CPI RAD VISION described in this submission is substantially equivalent to the predicate devices.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 15, 2013
Mr. Norm Morikawa QA Manager Communications and Power Industries Canada, Inc. 45 River Drive GEORGETOWN, ONTARIO, L7G2J4, CANADA
Re: K122726
Trade/Device Name: CPI Rad Vision Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: January 18, 2013 Received: February 1, 2013
Dear Mr. Morikawa:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
4
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Smh
5270
Janine M. Morris Director, Diagnostic X-Ray Systems Branch Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
for
Enclosure
5
Indications for Use
K122726 510(k) Number (if known):
CPI RAD VISION
Indications For Use:
Device Name:
CPI RAD VISION is a digital imaging system intended for the capture and display of radiographic images of human anatomy, as part of a diagnostic x-ray system. It is intended for use in general radiographic examinations and applications. The device is not intended for mammographic, fluoroscopic or angiographic applications.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Image /page/5/Picture/10 description: The image shows a logo with the letters FDA. The letters are stylized and appear to be hand-drawn. The logo is black and white and has a rough, textured appearance. The letters are connected and overlapping, making the logo appear complex and intricate.
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(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health