K Number

Device Name

PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels

Manufacturer

Pixxgen Corporation

Date Cleared

2018-05-24

(41 days)

Product Code

MQB

Regulation Number

892.1680

Intended Use

Indicated for use in general radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures, excluding fluoroscopic, angiographic, and mammographic applications

Device Description

The PIXX series are digital radiography systems, featuring an integrated flat panel digital detector (FPD). They are designed to perform digital radiographic examinations as a replacement for conventional film. This integrated platform provides the benefits of PACS with the advantages of digital radiography for a filmless environment and improves cost effectiveness. The major functions and principle of operation of the updated panels are the same as our previous panel retaining the Wi-Fi wireless features.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K152151

Reference Devices

K152151

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard digital radiography system and does not mention any AI or ML capabilities.

Therapeutic

No
This device is for diagnostic imaging, not for treating diseases or conditions.

Diagnostic

Yes

The device is intended for use in "general-purpose diagnostic procedures" and performs "digital radiographic examinations" which are inherently diagnostic in nature.

SaMD (Software as a Medical Device)

The device description explicitly states it features an "integrated flat panel digital detector (FPD)" and is a "digital radiography system," indicating it includes hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The description clearly states that this device is a digital radiography system intended for acquiring radiographic images of human anatomy using X-rays. It is a replacement for traditional film/screen systems used in diagnostic imaging.
Lack of Biological Sample Analysis: There is no mention of the device analyzing biological samples. Its function is to capture and process images generated by X-ray interaction with the body.

Therefore, this device falls under the category of a medical imaging device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

MQB

Device Description

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

Clinical images were acquired and evaluated by a board certified radiologist who concluded the images from the new panels are as good as or better than the images acquired with the predicate panel, as required by the applicable FDA guidance on solid state imaging devices. The core technology of the panel remains the same.

Key Metrics

Not Found

Predicate Device(s)

K152151

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

May 24, 2018

PIXXGEN Corporation % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES FL 34114

Re: K180976

Trade/Device Name: PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-Ray Receptor Panels Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: April 25, 2018 Received: April 27, 2018

Dear Mr. Kamm:

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. 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);

Page 2 - Daniel Kamm

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Hole 2. Nils

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known) K180976

Device Name

PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-Ray Receptor Panels

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary 510(k) Number K180976 PIXXGEN Corporation 5F, SMART BAY, 123, Beolmal-ro, Dongan-gu, Anyang-si, Gyeonggi-do, 14056, Korea Tel +82.70.4846.8888 Date Prepared: May 18, 2018 Contact: Young Kim, President

1. Identification of the Device: Proprietary-Trade Names: PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-Ray Receptor Panels Device: Solid State X-Ray Imager (Flat Panel/Digital Imager) Regulation Name: Stationary x-ray system. Product Code: MQB Regulation Number: 892.1680 Device Class: 2
1. Equivalent legally marketed device: ATAL 9, K152151, Atlaim Corporation. (Company name changed now to Pixxgen Corporation)

Device:	Solid State X-Ray Imager (Flat Panel/Digital Imager)
Regulation Name:	Stationary x-ray system.
Product Code:	MQB
Regulation Number:	892.1680
Device Class:	2

1. Indications for Use (intended use) Indicated for use in general radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures, excluding fluoroscopic, and mammographic applications.
1. Description of the Device:

1. Safety and Effectiveness, comparison to predicate device. The results of clinical image inspection, bench, and test laboratory results indicates that the new device is as safe and effective as the predicate device. Clinical images collected demonstrate equal or better image quality as compared to our predicate.

6. Substantial Equivalence Chart

	ATAL 9, K152151	PIXX 1717	PIXX 1417	PIXX 1212
Intended Use	Indicated for use in general
radiographic images of human
anatomy. It is intended to
replace radiographic film/screen
systems in all general-purpose
diagnostic procedures, excluding
fluoroscopic, angiographic, and
mammographic applications	UNCHANGED	UNCHANGED	UNCHANGED
Configuration	This submission is for the
Digital Panel and Software
only, no generator or stand
provided.	UNCHANGED	UNCHANGED	UNCHANGED
Pixel Pitch	139um	140um/168um	140 um	140 um
Limiting
Resolution	Over 3 lp/mm	SAME	SAME	SAME
DQE(CSI)	At 2 lp/mm 29.5%	At 2 lp/mm 26.5%	At 2 lp/mm 26.5%	At 2 lp/mm 26.5%
MTF(CSI)	At 2 lp/mm 42%	At 2 lp/mm 44%	At 2 lp/mm 44%	At 2 lp/mm 44%
DQE(GOS)	At 2 lp/mm 18	At 2 lp/mm 21	At 2 lp/mm 21	At 2 lp/mm 21
MTF(GOS)	At 2 lp/mm 33%	At 2 lp/mm 35%	At 2 lp/mm 35%	At 2 lp/mm 35%
DQE and MTF
Comments	The MTF and DQE measurements are very similar between our predicate and the new PIXX series of
digital panels. Some measurements are slightly higher, and some are very slightly lower. The 7% MTF
difference for CSI performance is comparable to the
possible measurement error.
A/D Conversion	16 bits	16 bits	16 bits	16 bits
Active Area	17 x 17 inch	17 x 17 inch	14 x 17 inch	12 x 12 inch
Dimensions(m
m)/
Weights(Kg)	460(W)x461(L)x15(H)/(2.9Kg
w/o Battery)(up to 10 hours
of battery life)	460(W)x461(L)x15(H)/
3.0Kg	385(W) x 460(L) x
15(H)/ 2.8Kg	308.5(W) x 319.5(L) x
15(H)/ 1.9Kg
Pixels	3,072x3,072	3,072 x 3,072	2,560 x 3,072	2,048 x 2,048
Software	Outputs a DICOM image	SAME as K152151
The software is
unchanged.	SAME as K152151
The software is
unchanged.	SAME as K152151
The software is
unchanged.
DICOM	Yes	Yes	Yes	Yes
Scintillator	Csl orGOS	UNCHANGED	UNCHANGED	UNCHANGED
Interface	Wired: Gigabit Ethernet
(1000BASE-T)
Wireless:IEEE802.11ac,
backward compatible	Wired: Gigabit
Ethernet
(1000BASE-T)
Wireless:
IEEE802.11ac,
backward compatible	Wired: Gigabit
Ethernet
(1000BASE-T)
Wireless:
IEEE802.11ac,
backward
compatible	Wired: Gigabit
Ethernet
(1000BASE-T)
Wireless:
IEEE802.11ac,
backward compatible
Power source	AC Line and/or Rechargeable
Lithium Battery	AC Line	AC Line	AC Line
	ATAL 9, K152151	PIXX 1717	PIXX 1417	PIXX 1212
Standards	Electrical Safety per IEC
60601-1 and EMC per IEC
60601-1-2 as well as
IEEE802.11ac. Meets FCC
requirements.	Electrical Safety per
IEC 60601-1:2012 and
EMC per IEC 60601-1-
22007+AC:2010
as well as
IEEE802.11ac. Meets
FCC requirements.	Electrical Safety per
IEC 60601-1:2012
and EMC per IEC
60601-1-
22007+AC:2010
as well as
IEEE802.11ac. Meets
FCC requirements.	Electrical Safety per
IEC 60601-1:2012 and
EMC per IEC 60601-1-
22007+AC:2010
as well as
IEEE802.11ac. Meets
FCC requirements.
Photos	Image: ATAL 9, K152151	Image: PIXX 1717	Image: PIXX 1417	Image: PIXX 1212

1. Summary of Bench Testing Conducted: IEC Standards were employed for: Electrical Safety, IEC60601-1 and Electromagnetic Compatibility, IEC60601-1-2 as shown in the comparison table above. MTF and DQE measurements, Risk Analysis and Software verification were conducted in accordance with the FDA guidance documents: Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices Guidance for Industry and Food and Drug Administration Staff and Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. As expected the DQE and MTF measurements show minimal differences, and the limiting resolution is the same. The software remains the same as in K152151. Wireless communication testing was performed to verify wireless connectivity. The device was also found to comply with FCC requirements for wireless operation. In addition, the following FDA Guidance Documents were consulted during the development of this device: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, Guidance for Industry and Food and Drug Administration Staff and Pediatric Information for X-ray Imaging Device Premarket Notifications.
1. Summary of Clinical Testing: Clinical images were acquired and evaluated by a board certified radiologist who concluded the images from the new panels are as good as or better than the images acquired with the predicate panel, as required by the applicable FDA guidance on solid state imaging devices. The core technology of the panel remains the same.
1. Conclusion: After analyzing bench, clinical image, and external laboratory testing to applicable standards, it is the conclusion of Pixxgen that the PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-Ray Receptor Panels are as safe and effective as the predicate device, have few technological differences, and has the identical indications for use, thus rendering them substantially equivalent to the predicate device.