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.

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.

AI/ML Overview

The provided text describes a 510(k) submission for the Kubtec DIGIVIEW 250, a digital radiography system. The submission focuses on demonstrating substantial equivalence to a predicate device (Canon CXDI-60G) rather than a comprehensive study against specific acceptance criteria for a new medical AI device. Therefore, much of the requested information (e.g., sample sizes for training/test sets, ground truth establishment, expert qualifications, MRMC studies) is not detailed in this document because it pertains to performance studies for an AI or novel diagnostic device, which is not the nature of this 510(k) submission.

Here's the information that can be extracted or inferred from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in the sense of predefined thresholds for clinical performance metrics (like sensitivity/specificity) against a clinical gold standard. Instead, it compares technical specifications to a predicate device to demonstrate substantial equivalence. The "acceptance criteria" can be inferred as matching or exceeding the predicate device's technical specifications and intended use.

Characteristic	Acceptance Criteria (Predicate Device Performance)	Reported Device Performance (Kubtec DIGIVIEW 250)
Digital Resolution (Pixels)	1464 x 1776 pixels (2.6 million)	2000 x 2560 pixels (5.12 million)
Digital Resolution (lp/mm)	3.1 lp/mm	5.2 lp/mm
Pixel Pitch	160 microns	96 microns
Bit Depth	14 bit	14 bit
Image Readout	approx. 3 seconds	750 milliseconds
Dynamic Range	80 dB	78 dB
Detector Type	Amorphous Silicon	CMOS
Scintillator	GdOS	GdOS
Interface	Ethernet	Ethernet
DICOM	Dicom compatible	Dicom compatible
Imaging Area	230 x 280 mm	192 x 246 mm
Housing Size	344 x 380 x 22.5 mm	355 x 285 x 24 mm
Operating Temperature	5 - 35 Degrees C	0 - 50 Degrees C
Humidity	30 - 75% R.H.	0 - 80% R.H.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the "acceptance criteria" (i.e., substantial equivalence) is the non-clinical testing and design control activities mentioned. The submission states: "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." This typically involves laboratory testing of the physical and imaging characteristics of the device against industry standards and the specifications of the predicate.

2. Sample Size Used for the Test Set and Data Provenance:

Test Set Sample Size: Not specified. The document does not detail a clinical test set with patient data. The "testing" referred to is non-clinical, likely engineering and performance measurements.
Data Provenance: Not applicable in the context of clinical data for a test set. The testing is based on device performance in a lab setting.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. There is no mention of human experts establishing ground truth for a clinical test set, as this is a device for image capture, not an image interpretation AI.

4. Adjudication Method for the Test Set:

Not applicable. No clinical test set or human interpretation is detailed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. The document makes no mention of an MRMC study. This type of study is typically done for AI-powered diagnostic tools to assess the impact of AI on human reader performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Yes, in a way. The "performance data, non-clinical testing" can be considered a standalone assessment of the device's technical capabilities (e.g., resolution, dynamic range, readout speed) without human intervention in the specific output generation. However, it's a hardware device, not an AI algorithm.

7. Type of Ground Truth Used:

For technical specifications: Engineering measurements, internationally recognized standards (e.g., for resolution, dynamic range), and the published specifications of the predicate device. There is no "ground truth" for clinical diagnoses as the device itself is not making diagnostic interpretations.

8. Sample Size for the Training Set:

Not applicable. This device is a hardware digital radiography system, not an AI model that requires a training set of data.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for an AI model.

Summary

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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:

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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 VACout)	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
Operatingtemperature:	0 -50 Degrees C	5 -35 Degrees C
Humidity:	0 - 80% R.H.	30 -75% R.H.
Method of Control:	Software Driven	Software Driven
PerformanceStandard:	21 CFR 1020.30	21 CFR 1020.30
Classificationname:	Solid State X-ray imager	Solid State X-ray imager
Detector Type:	CMOS	Amorphous Silicon
Housing:	Molded plastic with roundedcorners and built-in handle	Molded plastic with roundedcorners and built-in handle

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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.

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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

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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

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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:

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

Regulation Number and Section

§ 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.