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 for adult, pediatric and neonatal examinations. The DX-D Imaging Package may be used wherever conventional screen-film systems, CR or DR systems may be used.

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

Device Description

The device is a direct radiography imaging system of similar design and construction to the original (predicate) version of the device. Agfa's DX-D Imaging Package uses the company's familiar NX workstation with MUSICA2™ image processing and flat panel detectors of the scintillator-photodetector type. Flat panel detectors with scintillators of both Cesium Iodide (Csl) and Gadolinium Oxysulfide (GOS) are available. The device is used to capture and directly digitize x-ray images without a separate digitizer. This new version includes optional image processing algorithms for adult, pediatric and neonatal images that were previously cleared for use in Agfa's computed radiography systems.

The device uses a direct conversion process to convert x-rays into a digital signal. X-rays incident on the scintillator layer of the detector generate light that is absorbed by photo-detectors, converted to a digital signal and sent to the workstation the data is processed by Agfa's MUSICA image processing software. The acronym MUSICA stands for Multi-Stage-Image-Contrast-Amplification. MUSICA acts on the acquired images to preferentially enhance the diagnostically relevant, moderate and subtle contrasts.

Principles of operation and technological characteristics of the new and predicate devices are the same.

AI/ML Overview

While the provided text mentions that "Performance data including laboratory image quality measurements and image comparison studies by independent radiologists are adequate to ensure equivalence," it does not provide specific acceptance criteria or detailed results of these studies. Therefore, a table of acceptance criteria and reported device performance cannot be generated with the given information.

Here's an analysis of what can be extracted and what is missing:

Acceptance Criteria and Study Details (Based on Provided Text)

The document states that the performance data from "laboratory image quality measurements" and "image comparison studies by independent radiologists" were "adequate to ensure equivalence." However, no specific metrics, targets, or results for these studies are provided.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not specified in the document. The document states that performance data, including laboratory image quality measurements and image comparison studies by independent radiologists, were "adequate to ensure equivalence," but it does not detail these criteria or the specific performance results against them.	Not specified in the document. The document attests to the adequacy of the data without providing quantitative results or metrics.

2. Sample Size and Data Provenance for Test Set

Sample Size: Not specified.
Data Provenance: The document mentions "In-hospital image quality comparisons," implying diagnostic images from a clinical setting. It does not specify the country of origin.
Retrospective/Prospective: Not specified.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: Not specified. The document mentions "independent radiologists."
Qualifications of Experts: The document states "qualified independent radiologists." Specific experience (e.g., "10 years of experience") is not provided.

4. Adjudication Method for Test Set

Adjudication Method: Not specified.

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

Was it done?: Not explicitly stated as an MRMC study in the standard terminology, but the document mentions "image comparison studies by independent radiologists" and "In-hospital image quality comparisons have been conducted with qualified independent radiologists." This suggests a human reader component. However, it's unclear if this was a comparative effectiveness study involving AI assistance.
Effect Size of Human Readers with AI vs. Without AI Assistance: Not applicable, as the document doesn't describe AI-assisted reading or its effect size. The new version includes "optional image processing algorithms," but the study described is for the device's imaging quality, not human-in-the-loop performance with new algorithms.

6. Standalone (Algorithm Only) Performance Study

Was it done?: No. The document describes the device as an imaging system, not a standalone AI algorithm for interpretation. The "optional image processing algorithms" are part of the overall imaging package, and the performance validation is for the "complete system," not the algorithm in isolation for diagnostic accuracy.

7. Type of Ground Truth Used

Type of Ground Truth: Implied to be expert consensus/radiologist interpretation. The document refers to "image comparison studies by independent radiologists" and "in-hospital image quality comparisons." Pathology or outcomes data are not mentioned.

8. Sample Size for Training Set

Sample Size: Not applicable. This device is an X-ray imaging system, not a machine learning algorithm that requires a "training set" in the conventional sense for diagnostic image analysis. The "new version includes optional image processing algorithms for adult, pediatric and neonatal images that were previously cleared." These algorithms would have been developed and validated, but the document doesn't provide details on their training data.

9. How Ground Truth for Training Set Was Established

How Ground Truth for Training Set Was Established: Not applicable (see point 8).

Summary

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Agfa HealthCare NV Premarket Notification: DX-D Imaging Package MAR 1 1 2013

K122736
Page 1 of 4

్ల గ్రామం

510(K) SUMMARY: AGFA DX-D Imaging Package

Common/Classification Name: Stationary X-ray System, 21 CFR 892.1680 Proprietary Name: DX-D Imaging Package Agfa HealthCare N.V. Septestraat 27 B-2640 Mortsel Belgium Contact: Phil Cuscuna, Prepared: September 4, 2012 Telephone: (416) 240-7317 Facsimile: (416) 240-7359

LEGALLY MARKETED PREDICATE DEVICES A.

This is a 510(k) for the latest version of Agfa's DX-D Imaging Package, a solid state, flat-panel x-ray imaging system.

DEVICE DESCRIPTION B.

Principles of operation and technological characteristics of the new and predicate devices are the same.

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C. INTENDED USE

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

D. SUBSTANTIAL EQUIVALENCE SUMMARY

Agfa's DX-D Imaging Package has an Indications For Use statement similar to the statements for the predicate devices, K090672 and K092669. Intended uses are the same. The devices have the same technological characteristics.

The new device is physically equivalent to the previous version. K092669 but includes the optional image processing settings utilized in the computed radiography predicate, K090672. Performance data including laboratory image quality measurements and image comparison studies by independent radiologists are adequate to ensure equivalence.

Differences in devices do not alter the intended diagnostic effect.

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K122736
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PRODUCT COMPARISON TABLE
	DX-D Imaging Package(New Device)	AGFA DX-D ImagingPackage(PREDICATE-K092669)	AGFA CR Systems withNX Workstations(PREDICATE-K090672)
Communications	Same as predicates	DICOM	DICOM
Flat Panel or ImagePlate	Same as K092669	Flat Panel Detector	Image Plates withCassettes
Detector Material	Same as K092669	Gadolinium Oxysulfide(GOS) orCesium lodide (CSI)scintillator	HD5.0 (CsBr:Eu)MD4.0 (BaSrFBrl:Eu)
Detector Sizes	Same as K092669	17x17 in.14x17 in.	14x17 in.14x14in.8x10 in.10x12 in
Active Matrix(14x17 in.)	Same as K092669	2560x3072	3408 x 4200 (HD5.0)2320 x 2832 (MD4.0)
Pixel size	Same as K092669	139 µm	100 µm
Dynamic Range	Same as K092669	14 bit	12 bit
Maximum ImageAcquisitions/hr.	Same as K092669	150	100
Power Supply	Same as predicates	50-60 Hz100-240V auto ranging	50-60 Hz100-240V auto ranging
OperatorWorkstation	Same as predicates	Agfa NX	Agfa NX
Image processing	Same as K090672	MUSICA2	MUSICA2MUSICA2 PlatinumMUSICA2 Neonatal
Operating system	Windows 7	Windows XP Pro	Windows XP Pro
Display System	Same as predicates	Standard PC display orseparately cleared medicaldisplay (e.g. K051901)	Standard PC display orseparately cleared medicaldisplay (e.g. K051901)

TECHNOLOGICAL CHARACTERISTICS E.

Agfa's DX-D Imaging Package is a scintillator-photodetector type solid state x-ray imaging system. The NX workstation allows users to view and processes images, and forward them to other devices (e.g. a PACS or printer).

The DX-D Imaging Package is integrated with compatible x-ray systems.

TESTING F.

Image quality measurement data has been provided. In-hospital image quality comparisons have been conducted with qualified independent radiologists as well. Sample images have been

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K122736
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provided.

Performance of the complete system has been validated.

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

PRODUCT STANDARDS

IEC 60601-1: Medical electrical equipment Part 1: General requirements for basic safety . and essential performance, plus collateral standard: Electromagnetic compatibility requirements and tests.
IEC 60601-1-2: Medical electrical equipment Part 1-2: General Requirements For Safety -. Collateral Standard: Electromagnetic Compatibility - Requirements And Tests
ACR/NEMA PS3.1-3.18: Digital Imaging and Communications in Medicine (DICOM) .

MANAGEMENT STANDARDS

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

CONCLUSIONS G.

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.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

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

March 11, 2013

Agfa Healthcare, N.V. % Mr. David Ledwig Principal Consultant Practical Compliance, LLC P.O. Box 1927 BREVARD, NC 28712

Re: K122736

Trade/Device Name: DX-D Imaging Package Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: February 08, 2013 Received: February 12, 2013

Dear Mr. Ledwig:

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

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Page 2 - Mr. Ledwig

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.

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K122736

Device Name: DX-D Imaging Package

Indications For Use:

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

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)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510 (k) : K122736

Page 1 of 1

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.