Agfa's DX-D Imaging Package is indicated for use in general projection radiographic applications to capture for display diagnostic quality radiographic images of human anatomy. The DX-D Imaging Package may be used wherever conventional screen-film systems may be used.

Agfa's DX-D Imaging Package is not indicated for use in mammography.

Device Description

Agfa's DX-D Imaging Package is a solid state flat panel x-ray system, a direct radiography (DR) system (product code MQB) intended to capture images of the human body. It is a combination of Agfa's NX workstation and one or more flat-panel detectors.

This submission is to add the DR10s and DR14s Flat Panel Detectors to Agfa's DX-D Imaging Package portfolio. The DX-D Imaging Package with the DR 10s and DR 14s wireless panels will be labeled as the Pixium 2430EZ and Pixium 3543EZ. DR 10s and DR 14s are commercial trade names used by Agfa HealthCare for marketing purposes only.

Principles of operation and technological characteristics of the new and predicate device are the same. There are no changes to the intended use/indications of the new device is physically and electronically identical to the predicate, K142184. It uses the same workstation and the similatorphotodetector flat panel detectors to capture and digitize the images as predicate K142184.

AI/ML Overview

This document describes the 510(k) summary for Agfa's DX-D Imaging Package, focusing on the newly added DR10s and DR14s Flat Panel Detectors. The submission aims to demonstrate substantial equivalence to a predicate device (K142184).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a dedicated "acceptance criteria" table with specific quantitative thresholds. Instead, the acceptance criteria are implied to be equivalence to the predicate device (K142184) and performance falling within expected parameters for radiographic systems. The reported device performance is presented through comparison with other Agfa flat-panel detectors on the market, including the predicate.

Below is a table summarizing the performance characteristics of the new detectors (DR 10s, DR 14s) and the predicate (represented by DX-D 10, DX-D 20, DX-D 40 from the comparison table, as the predicate K142184's individual detector specs aren't explicitly broken out separately):

Characteristic	DX-D 10 Flat-Panel Detector (Predicate Example)	DR 10s Wireless Detector (New Device)	DR 14s Wireless Detector (New Device)	Acceptance Criteria (Implied)	Reported Device Performance (Summary)
Scintillator	CsI, GOS	CsI	CsI, GOS	Equivalent to predicate (CsI, GOS)	DR 10s uses CsI, DR 14s uses CsI, GOS. Deemed equivalent.
Cassette size	35x43cm/14x17in	24x30cm	35x43cm/14x17in	Appropriate for general radiography.	Different sizes, but appropriate for general radiography.
Pixel Size	139 µm	148 µm	148 µm	Comparable to predicate (139-140 µm).	Slightly larger pixel size but deemed equivalent.
A/D Conversion	14 bits	16 bits	16 bits	Comparable to predicate (14 bits).	Higher (16 bits) – considered an improvement.
Interface	Ethernet	AED & Synchronized	AED & Synchronized	Reliable interface.	AED & Synchronized.
Communication	Tethered	Wireless	Wireless	Reliable communication.	Wireless (new feature).
Power	I/O Interface Box: 100-240 VAC, 47-63 Hz	Battery: replaceable & rechargeable	Battery: replaceable & rechargeable	Reliable power.	Battery-powered for wireless operation.
Weight	3.9 kg (8.6 lbs)	1.6 kg (3.53 lbs)	2.8 kg (6.17 lbs)	Ergonomically acceptable.	Lighter than predicate examples (due to wireless nature).
DQE @ 1lp/mm	0.530/0.608	0.523	0.521/0.292	Equivalent to predicate.	Comparable values, "equivalent to other flat-panel detectors."
DQE @ 2lp/mm	0.219/0.298	0.476	0.449/0.189	Equivalent to predicate.	Comparable values, "equivalent to other flat-panel detectors."
DQE @ 3lp/mm	0.092/0.147	0.295	0.296/0.071	Equivalent to predicate.	Comparable values, "equivalent to other flat-panel detectors."
MTF @ 1lp/mm	0.205/0.456	0.637	0.638/0.526	Equivalent to predicate.	Comparable values, "equivalent to other flat-panel detectors."
MTF @ 2lp/mm	0.106/0.304	0.360	0.363/0.208	Equivalent to predicate.	Comparable values, "equivalent to other flat-panel detectors."
MTF @ 3lp/mm	0.092/0.147	0.199	0.198/0.081	Equivalent to predicate.	Comparable values, "equivalent to other flat-panel detectors."
Image Acquisition/hr.	150	240	240	At least equivalent to predicate (150).	Higher (240) – considered an improvement.

The overall acceptance criteria for the study is "Substantial Equivalence" to the predicate device (K142184), demonstrated through:

Identical Indications for Use.
Same principles of operation and technological characteristics (despite some hardware differences).
Performance data (laboratory and clinical evaluations) ensuring equivalence.

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

Test Set Sample Size:
- For laboratory image quality (DQE, MTF) comparisons and grid evaluation: The document does not specify a numerical sample size in terms of images or measurements. It states "equivalent test protocols as used for the cleared detectors" were used and the results "confirmed that the DX-D Imaging Package with DR 10sC, DR14sC, and DR14sG flat-panel detectors was equivalent to other flat-panel detectors Agfa currently markets including the predicate (K142184)."
- For usability and functionality evaluations: Not specified.
- For Image Quality Validation testing (using anthropomorphic phantoms): Not specified.
- For in-hospital image quality comparisons ("clinical evaluations"): "anonymized" patient images were utilized, but the number of images or cases is not specified.
Data Provenance: The data appears to be retrospective (for human image data, implied from "anonymized to remove all identifying patient information" and "No animal or clinical studies were performed in the development of the new device. No patient treatment was provided or withheld.") and laboratory-generated (for DQE, MTF, grid, usability, and phantom studies). The country of origin is not explicitly stated.

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

For laboratory image quality, grid evaluation, usability/functionality:
- "qualified individuals employed by the sponsor" conducted these evaluations.
- "qualified independent radiographers" conducted usability and functionality evaluations.
- "a qualified internal radiographer" conducted the grid evaluation.
- "qualified independent radiographers" evaluated anthropomorphic phantoms.
For in-hospital image quality comparisons:
- "qualified independent radiologists" conducted these comparisons.
Qualifications: "Qualified independent radiographers" and "qualified independent radiologists" are mentioned. Specific experience levels (e.g., "10 years of experience") are not provided. The term "qualified" implies they possess the necessary expertise for the task.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). The "clinical evaluations" and "in-hospital image quality comparisons" mention "qualified independent radiologists" in plural, suggesting a consensus or comparison approach among them, but details are not provided.

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

No MRMC comparative effectiveness study was done in the sense of measuring human reader improvement with vs. without AI assistance.
The studies conducted were focused on demonstrating that the new device's image quality and performance were equivalent to the predicate device and other established systems, meaning human readers would perform similarly with the new device as with the predicate.

6. Standalone (Algorithm Only) Performance Study

No standalone algorithm performance (AI-only) study was done for diagnostic interpretation. The device is an imaging package (hardware detectors and workstation) for capturing and displaying images, not an AI diagnostic algorithm.

7. Type of Ground Truth Used

For laboratory image quality (DQE, MTF, grid): The "ground truth" is based on physical measurements and standardized test protocols.
For usability and functionality: The "ground truth" is based on expert assessment by radiographers against pre-defined workflow and compatibility requirements.
For image quality validation (phantoms): The "ground truth" is based on expert assessment by radiographers of the generated images, likely comparing features to expected phantom characteristics and established image quality standards.
For in-hospital image quality comparisons: The "ground truth" is implicitly based on radiological expert consensus (potentially with existing patient reports as a reference, though this is not specified), primarily for qualitative comparison against images produced by predicate devices.

8. Sample Size for the Training Set

The document does not mention a training set, as this device (an X-ray imaging package) is not an AI diagnostic device that requires a training set in the typical machine learning sense. The "software validation testing" refers to verification and validation of the software components against predefined requirements, not training a machine learning model.

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

Not applicable, as no training set for an AI algorithm is mentioned or implied.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of two main elements: a circular text element and a symbolic graphic. The text element reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion. The graphic element features a stylized representation of human profiles, stacked one behind the other, creating a sense of depth and unity.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 22, 2016

Agfa HealthCare N.V. % ShaeAnn Cavanagh, RAC Regulatory Affairs Manager NA AGFA Healthcare 10 South Academy Street GREENVILLE SC 29601

Re: K161368

Trade/Device Name: DX-D Imaging Package Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: August 26, 2016 Received: August 29, 2016

Dear Ms. Cavanagh:

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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'Hara

For

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.

510(k) Number (if known)	K161368
Device Name	DX-D Imaging Package
Indications for Use (Describe)	Agfa's DX-D Imaging Package is indicated for use in general projection radiographic applications to capture for display diagnostic quality radiographic images of human anatomy. The DX-D Imaging Package may be used wherever conventional screen-film systems may be be used.
	Agfa's DX-D Imaging Package is not indicated for use in mammography.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."

FORM FDA 3881 (1/14)	Page 1 of 1	PSC Publishing Services (301) 443-6740
----------------------	-------------	----------------------------------------

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510(K) SUMMARY

Agfa's DX-D Imaging Package - DR 10s & DR 14s Detectors

I. SUBMITTER

Agfa HealthCare N.V. Septestraat 27 B-2640 Mortsel Belgium

Contact: Koen Vervoort, Prepared: May 16, 2016 Telephone: +32-34444-7368

II. DEVICE

Name of Device: DX-D Imaging Package Classification Name: Stationary X-Ray System Regulatory Classification: Class II, 21 CFR 892.1680 Product Code: MQB

IJII. PREDICATE DEVICES

This is a 510(k) for Agfa's DX-D Imaging Package, a solid state, flat panel x-ray imaging device. It is substantially equivalent to Agfa's DX-D Imaging Package (K142184).

DEVICE DESCRIPTION IV.

Laboratory data and image quality evaluations conducted with independent radiologists confirm that performance is equivalent to the predicate.

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Agfa HealthCare NV
Premarket Notification: DX-D Imaging Package – DR 10s and DR 14s Detectors

Performance	DX-D 10 Flat-	DX-D 20 Flat-	DX-D 40 Flat-	DR 10s	DR 14s Wireless
Characteristics	Panel Detector	Panel Detector	Panel Instant	Wireless	Detector
		(Handle)	Detector	Detector
Scintillator	CsI, GOS	CsI, GOS	CsI, GOS	CsI	CsI, GOS
Cassette size	35x43cm/14x17in	35x43cm/14x17in	35x43cm/14x17in	24x30cm	35x43cm/14x17in
Pixel Size	139 µm	139 µm	140 µm	148 µm	148 µm
A/D Conversion	14 bits	14 bits	14 bits	16 bits	16 bits
Interface to	Ethernet	Ethernet	AED &	AED &	AED &
Generator			Synchronized	Synchronized	Synchronized
Communication	Tethered	Tethered	Wireless	Wireless	Wireless
Power	I/O Interface Box:	I/O Interface Box:	Battery:	Battery:	Battery:
	100-240 VAC,	100-240 VAC, 47-	replaceable &	replaceable &	replaceable &
	47-63 Hz	63 Hz	rechargeable	rechargeable	rechargeable
Weight	3.9 kg (8.6 lbs)	4.9 kg (10.8 lbs)	3.4 kg (7.5 lbs)	1.6 kg (3.53 lbs)	2.8 kg (6.17 lbs)
DQE	1lp/mm - 0.530/0.608;	1lp/mm - 0.530/0.608;	1lp/mm - 0.38/0.40;	1lp/mm - 0.523;	1lp/mm - 0.521/0.292;
	2lp/mm - 0.219/0.298;	2lp/mm - 0.219/0.298;	2lp/mm - 0.23/0.24;	2lp/mm - 0.476;	2lp/mm - 0.449/0.189;
	3lp/mm - 0.092/0.147	3lp/mm - 0.092/0.147	3lp/mm - 0.13/0.11	3lp/mm - 0.295	3lp/mm - 0.296/0.071
MTF	1lp/mm - 0.205/0.456;	1lp/mm - 0.205/0.456;	1lp/mm - 0.570/0.578;	1lp/mm - 0.637:	1lp/mm - 0.638/0.526;
	2lp/mm - 0.106/0.304;	2lp/mm - 0.106/0.304;	2lp/mm - 0.269/0.279;	2lp/mm - 0.360:	2lp/mm - 0.363/0.208;
	3lp/mm - 0.092/0.147	3lp/mm - 0.092/0.147	3lp/mm - 0.142/0.150	3lp/mm - 0.199	3lp/mm - 0.198/0.081

Configuration information can be found in the DR 10s and DR 14s User Manuals. The DR 10s and DR 14s detectors can be integrated in an X-ray system that communicates to a workstation. The DR 10s and DR 14s Service Manual details the possible configurations and integrations with the NX workstation and X-ray generator. All of Agfa HealthCare's DR and CR x-ray systems (i.e. DX-D 100-K103597, DX-D 300-K103050, DX-D 600-K112670, DR 400-K141192, DR 600-K152639, CR 10-X-K121948, and CR 12-X-K131408) will integrate with the new device. The NX8900 Service Manual, Chapter 4 and associated appendices addresses the installation and configuration with other system components.

INDICATIONS FOR USE v.

Agfa's DX-D Imaging Package is not indicated for use in mammography.

Intended use has not changed as a result of any labeling modification(s).

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VI. COMPARISON OF TEDCHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICES

Principles of operation and technological characteristics of the new and predicate device are the same. There are no changes to the intended use/indications of the device. The new device is physically and electronically identical to the predicate, K142184. It uses the same workstation and the similar scintillator-photodetector flat panel detectors to capture and digitize the images as predicate K142184. There are no differences between the device and predicates K142184 that impact safety and effectiveness.

Performance data including laboratory image quality measurements (DQE), image quality clinical evaluations, and spatial frequency (MTF), grid test, and performance/functionality and usability data are adequate to ensure equivalence.

Agfa's DX-D Imaging Package has an Indications For Use statement identical to the predicate device (K142184). Intended uses are the same. The devices have the same technological characteristics.

The DX-D Imaging Package indications for use statement is substantially equivalent to the predicate device (K142184). The DX-D Imaging Package and predicate device (K142184) include the statement that the device is not indicated for mammography. The DX-D Imaging Package and predicate device (K142184) describe the imaging applications may be used utilized where screen-film systems exist. Differences in devices do not alter the intended diagnostic effect.

The table on the next page compares these technological characteristics.

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PRODUCT COMPARISON TABLE
	DX-D Img Pkg(New Device)	AGFA DX-D Imaging Package(PREDICATE-K142184)
Communications	Wireless	DICOM
Flat Panel	Same as Predicate	Flat Panel Detector
Detector Material	Same as Predicate	Gadolinium Oxysulfide (GOS) orCesium Iodide (CsI) scintillator
Detector Sizes	10x12 in14x17in	17x17 in.14x17 in.
Active Matrix (14x17 in.)	2400 x 2880	2560 x 3072
Pixel size	148 µm	140 µm
Dynamic Range	16 bits	14 bit
Maximum ImageAcquisitions/hr.	240	150
Power Supply	+12V 1A DC Battery	50-60 Hz100-240V auto ranging
Operator Workstation	Same as Predicate	Agfa NX
Image processing	Same as Predicate	MUSICA
Operating system	Same as Predicate	Windows 7
Display System	Same as Predicate	Separately cleared medical display(K051901)
Indications for Use	Same as Predicate	Agfa's DX-D Imaging Package is indicatedfor use in general projection radiographicapplications to capture for display diagnosticquality radiographic images of humananatomy. The DX-D Imaging Package maybe used wherever conventional screen-filmsystems may be used.Agfa's DX-D Imaging Package is notindicated for use in mammography.

VII. PERFORMANCE DATA

Laboratory testing and software testing (for a moderate level of concern device) using equivalent test protocols as used for the cleared detectors were evaluated by qualified individuals employed by the sponsor to demonstrate that adequate design controls (according to 21 CFR 820.30) were in place.

Laboratory image quality measurements (DQE), image quality clinical evaluations, and spatial frequency (MTF), performance/functionality and usability data, and grid evaluation data have been provided.

In-hospital image quality comparisons have been conducted with qualified independent radiologists as well.

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Where patient images were utilized, they were first anonymized to remove all identifying patient information. No animal or clinical studies were performed in the development of the new device. No patient treatment was provided or withheld.

Bench Testing

Image quality measurement data (DQE), spatial frequency (MTF) data, performance/functionality data, usability data, and grid evaluation have been provided. No patient treatment was provided or withheld. No clinical or animal testing was performed in the development of the DX-D Imaging Package.

Laboratory image quality (DOE) comparison and spatial frequency (MTF) evaluation of ● the DR 10sC. DR14sC. and DR14sG with other Agfa HealthCare flat-panel detectors currently on the market including the predicate (K142184). The test results confirmed that the DX-D Imaging Package with DR 10sC, DR14sC, and DR14sG flat-panel detectors was equivalent to other flat-panel detectors Agfa currently markets including the predicate (K142184).
Usability and functionality evaluations were conducted with qualified independent ● radiographers. The results of these tests fell within the acceptance criteria for all of the flat-panel detectors; the DX-D Imaging Package supports a radiographic workflow including calibration, compatibility, linear dose and dynamic ranges, and sensitivity.
Grid Evaluation was conducted with a qualified internal radiographer. The results of the grid evaluation of the chest, skull, and pelvis remained consistent with other Agfa HealthCare flat-panel detectors currently on the market including the predicate (K142184).. The intended use is fulfilled using different flat-panel detectors.
Image Quality Validation testing was conducted using anthropomorphic phantoms and ● evaluated by qualified independent radiographers. The test results indicated that the DR 10sC, DR14sC, and DR14sG flat-panel detectors have at least the same if not better image quality than other flat-panel detectors currently on the market.

Software Validation Testing

Verification and validation plans comprise of test protocols. The software components of the device have been certified and validated. During the final risk analysis meeting, the risk management team concluded that the medical risk is no greater than with conventional x-ray film previously released to the field.

For the DR 10s and DR 14s (XRDi17 software) there is only one risk identified in the Broadly Acceptable Region and no identified residual risks in the ALARP region after mitigation. Zero risks were identified in the Not Acceptable Region. Therefore, the device is assumed to be safe, the benefits of the device are assumed to outweigh the residual risk.

There are no identified residual risks for the released NX software versions NX8900 (NX Juno) in the ALARP region after mitigation. Only one risk was identified in the Broadly Acceptable Region after mitigation. Therefore, the device is assumed to be safe, the device are assumed to outweigh the residual risk.

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The term "Level of Concern" means the level of risk that the software device is determined to be if the software were to fail. The Level of Concern for the NX 8900 device has been determined to be moderate and the Level of Concern for the XRDi17 software has been determined to be minor.

The product, manufacturing and development processes conform to product safety and medical imaging standards including:

PRODUCT STANDARDS

IEC 60601-1: 2012 Medical Electrical Equipment: General Requirements for Safety and Essential Performance.
IEC 60601-1-2: 2014-4 Medical Electrical Equipment - Part 1-2: General Requirements for Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility -Requirements and Tests.

QUALITY MANAGEMENT STANDARDS

ISO 14971:2007 Application of Risk Management to Medical Devices ●
ISO 13485:2003 Medical Devices Quality Management Systems Requirements For ● Regulatory purposes

Summary

Based on the performance data as documented in the above testing. DX-D Imaging Package is found to have a safety and effectiveness profile that is similar to the predicate devices.

GUIDANCE DOCUMENTS VIII.

The applicant is aware of the following guidance documents that apply to products of this type:

Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices (August ● 1999).
o Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 2005).
Off-the-Shelf Software Use in Medical Devices (September 1999). ●
Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software ● (January 2005)
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (October 2014)

IX. CONCLUSIONS

Agfa's DX-D Imaging Package has an Indications For Use statement identical to the predicate device (K142184). Intended uses are the same. The devices have the same technological characteristics.

The DX-D Imaging Package indication for use is substantially equivalent to the predicate device

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(K142184). The DX-D Imaging Package and predicate device (K142184) include the statement that the device is not indicated for mammography. The DX-D Imaging Package and predicate device (K142184) describe the imaging applications may be used utilized where screen-film systems exist. Differences in devices do not alter the intended diagnostic effect.

The new device and the predicate device (K142184) are solid state imaging devices, Product Code MQB. Agfa's DX-D Imaging Package is substantially equivalent to the predicate device (K142184) in that it uses the same technology to capture and transmit images.

The DX-D Imaging Package with the DR 10s and DR 14s wireless panels will be labeled as the Pixium 2430EZ and Pixium 3543EZ. The DR 10s and DR 14s are commercial trade names used by Agfa HealthCare for marketing purposes only.

This 510(k) has demonstrated Substantial Equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.

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.