(339 days)
Not Found
No
The summary describes a digital x-ray imager and its associated software for image display, analysis, storage, and transmission. There is no mention of AI, ML, or any related concepts like deep learning, neural networks, or algorithms that learn from data to perform tasks beyond basic image processing and display. The focus is on the hardware (CMOS imager) and standard medical imaging software functionalities (DICOM compliance, PACS integration).
No.
The device is used for diagnostic imaging (generating radiographic images) and does not provide any therapeutic function or treatment.
Yes
The device is described as capturing digital x-ray images for "general purpose diagnostic procedures" and its software enables the "display and analysis of x-ray images," indicating its role in diagnosis.
No
The device description explicitly states it is a "CMOS based solid state x-ray imager" which is a hardware component, not solely software.
Based on the provided information, the Digiview 250 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the device is for "generating radiographic images of human anatomy" and "provide digital x-ray image capture for conventional film/screen radiographic examinations." This describes an in vivo diagnostic imaging device, not an in vitro diagnostic device.
- Device Description: The description details how the device captures X-ray photons that pass through anatomy and converts them into digital images. This is consistent with an X-ray imaging system used on a living patient.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body, which is the defining characteristic of an IVD.
Therefore, the Digiview 250 is a medical imaging device used for in vivo diagnostic purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The DIGIVIEW 250 is indicated for use in generating radiographic images of human anatomy. The device is intended to provide digital x-ray image capture for conventional film/screen radiographic examinations and replace radiographic film/screen systems in all general purpose diagnostic procedures. The device is not intended for mammography applications.
Product codes (comma separated list FDA assigned to the subject device)
MQB
Device Description
The Kubtec Digital Radiography DIGIVIEW 250 ® is a CMOS based solid state x-ray imager which has a 192 x 246 mm imaging area. The Digital Radiography DIGIVIEW 250® imager intercepts X-ray photons after they pass through anatomy and surrounding air and converts the X-ray photons into electrical signals. These resultant electric signals are converted into digital values which are transmitted for remote viewing. The DIGIVIEW 250 ® system features a DICOM 3.0 compliant software, DIGICOM. The DIGICOM software enables the display and analysis of x-ray images; either live (real time) or previously captured and the storage and transmission of these images to PACS systems.
Mentions image processing
Not Found
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)
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.
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
1103348
OCT 2 0 2011
510(k) Summary
Prepared: August 2, 2011
Submitter:
Company Name: KUB Technologies, Inc.
Company Address: 270 Rowe Avenue, Unit E
Milford, CT 06460
| Contact Person: | Mr. Vikram Butani |
|---|---|
| ----------------- | ------------------- |
(203) 364-8544 Phone Number:
- Fax Number: (203) 255-7494
Proposed Device:
| Reason For 510(k): New Model | |
|---|---|
| Trade Name: | Kubtec |
| Model Name: | Digiview 250 ® |
| Classification Name: | MQB, Solid State X-ray Imager |
| FDA 510(k) #: | K103348 |
Predicate Device:
| Trade Name: | Canon |
|---|---|
| Model Name: | CXDI-60G |
| Classification Name: | MQB, Solid State X-ray Imager |
| FDA 510(k) #: | K081648 |
Description Of Device:
The Kubtec Digital Radiography DIGIVIEW 250 ® is a CMOS based solid state x-ray imager which has a 192 x 246 mm imaging area. The Digital Radiography DIGIVIEW 250® imager intercepts X-ray photons after they pass through anatomy and surrounding air and converts the X-ray photons into electrical signals. These resultant electric signals are converted into digital values which are transmitted for remote viewing. The DIGIVIEW 250 ® system features a DICOM 3.0 compliant software, DIGICOM. The DIGICOM software enables the display and analysis of x-ray images; either live (real
1
time) or previously captured and the storage and transmission of these images to PACS systems.
Intended Use:
The DIGIVIEW 250 is indicated for use in generating radiographic images of human anatomy. The device is intended to provide digital x-ray image capture for conventional film/screen radiographic examinations and replace radiographic film/screen systems in all general purpose diagnostic procedures. The device is not intended for mammography applications.
Comparison Table:
Kubtec DIGIVIEW 250 ® (Proposed) To Canon CXDI-60G (Predicate):
| Characteristic: | Proposed Device | Predicate Device |
|---|---|---|
| Model: | Kubtec DIGIVIEW 250 ® | Canon CXDI-60G |
| Energy Source: | 100-240 V Power Box(6.6 VAC | |
| out) | 100-240V "Power Box" | |
| Digital Resolution | 2000 x 2560 pixels (5.12 million) | |
| 5.2 lp/mm | 1464 x 1776 pixels (2.6 million) | |
| 3.1 lp/mm | ||
| Pixel Pitch; | 96 microns | 160 microns |
| Bit depth: | 14 bit | 14 bit |
| DICOM: | Dicom compatible | Dicom compatible |
| Image readout: | 750 milliseconds | approx. 3 seconds |
| Interface: | Ethernet | Ethernet |
| Scintillator: | GdOS, gadolinium oxysulfide | GdOS, gadolinium oxysulfide |
| Dynamic range: | 78 dB | 80 dB |
| Operating | ||
| temperature: | 0 -50 Degrees C | 5 -35 Degrees C |
| Humidity: | 0 - 80% R.H. | 30 -75% R.H. |
| Method of Control: | Software Driven | Software Driven |
| Performance | ||
| Standard: | 21 CFR 1020.30 | 21 CFR 1020.30 |
| Classification | ||
| name: | Solid State X-ray imager | Solid State X-ray imager |
| Detector Type: | CMOS | Amorphous Silicon |
| Housing: | Molded plastic with rounded | |
| corners and built-in handle | Molded plastic with rounded | |
| corners and built-in handle |
2
Comparison:
The imaging area of the Kubtec DIGIVIEW 250 @ is 192 x 246 mm as compared to the 230 x 280mm area of the Canon CXDI-60G.
The Kubtec DIGIVIEW 250 ® has a housing measuring 355 x 285 x 24 mm compared to the Canon CXDI-60G housing at 344 x 380 x 22.5 mm and has a comparable shape with integral handle molded into the case.
Both the proposed and predicate device utilize GdOS (gadolinium oxysulfide) scintillators for the fluorescing screen.
The Kubtec DIGIVIEW 250 @ utilizes CMOS as its detector. Canon CXDI-60G uses amorphous silicon detectors. CMOS (complementary metal-oxide semiconductor) technology offers higher sensitivity and signal to noise performance with faster speed and better resolution.
The image readout time on the Kubtec DIGIVIEW 250 ® is 750 milliseconds as compared to the Canon CXDI-60G time of 3 seconds.
The resolution of the Kubtec DIGIVIEW 250 ® is 2,000 x 2,560 pixels (5.12 million) as compared to the predicate Canon CXDI60G of 1464 x 1776 pixels (2.6 million).
The pixel pitch of the Kubtec DIGIVIEW 250 @ is 96 microns compared to 160 microns on the Canon predicate device. The bit depth on both devices is 14 bits.
Both the proposed device, Kubtec DIGIVIEW 250 ® and the predicate device, Canon CXDI 60G are DICOM compatible, software driven, and utilize an Ethemet interface.
Conclusion:
The performance data, non-clinical testing, and design process demonstrate that the Kubtec DIGIVIEW 250 ® is as safe and effective as the Canon CXDI-60G, and has no new indications for use, thus rendering it substantially equivalent to the predicate device.
Based on the information submitted, similarity to the predicate device (Canon Digital Radiography CXDI-60G), and the results of our design control activities and non-clinical testing, it is the opinion of Kubtec that the Kubtec Digital Radiography DIGIVIEW 250 ® described in this submission is substantially equivalent to the predicate device.
3
Image /page/3/Picture/0 description: The image shows the logo of the Department of Health & Human Services. The logo includes the department's emblem on the left, followed by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in bold, sans-serif font. The emblem features a stylized human figure within a circular border, representing the department's focus on health and human well-being.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Vikram Butani President KUB Technologies 270 Rowe Avenue, Unit E MILFORD CT 06460
AUG 2 3 2013
Re: K103348
Trade/Device Name: Kubtec DIGIVIEW 250 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: September 30, 2011 Received: October 3, 2011
Dear Mr. Butani:
This letter corrects our substantially equivalent letter of October 20, 2011.
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 I ou may, dicross 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
4
medical device-related adverse events) (21 CFR 803); and good manufacturing practice medical device-lefatce adverse vromb) (21 cr or ots ) regulation (21 CFR Part 820). This letter requirements as set form in the quality of stam ( ( ) sogad in your Section 510(k) premarket whil anow you to begin marketing your act 10 m veence of your device to a legally marketed nontication. The PDF imanig of cassion 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 CFF Parts 801 and II you desire specific advice of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entiled, "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 under the MDK regulation (2) "It it 605), product go of only go 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 T ou may outlu 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
5
Image /page/5/Picture/0 description: The image shows the logo for Kubtec. The logo features a geometric design to the left of the word "kubtec" in a stylized font. Below the word "kubtec" is the tagline "GOING BEYOND THE SURFACE" in smaller, sans-serif font. The overall design is simple and professional.
Indications for Use
510(k) Number (if known): 长103348
Device Name: Kubtec DIGIVIEW 250
Indications For Use:
The Digiview 250 is indicated for use in generating radiographic images of human anatomy. The device is intended to provide digital x-ray image capture for conventional film/screen radiographic examinations and replace radiographic film/screen systems in all general purpose diagnostic procedures. The device is not intended for mammography applications.
Prescription Use X
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, The Office of In Vitro Diagnostics
Mary S. Pisto
(Division Sign-Off)
Office of In 510K
Page 1 of 1
270 Rowe Ave., Milford, CT 06460. Tel: (203) 364-8544; Fax: (203) 255-7494