The DR 600 is a GenRad X-ray imaging system used in hospitals, clinics and medical practices by radiographers, radiologists and physicists to make, process and view static X-ray radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts on adults and pediatric patients. Applications can be performed with the patient in sitting, standing or lying position.

The DR 600 is not intended for use in Mammography applications.

Device Description

Agfa's DR 600 is a solid state x-ray system, a direct radiography (DR) system (product code MOB) intended to capture images of the human body. The device is a combination of a conventional x-ray system with digital image capture. The DR 600 is a ceiling mounted tube and operator console with a motorized patient table and/or wall stand. The DR 600 uses Agfa's NX workstation with MUSICA2 ™ image processing and flat-panel detectors of the scintillatorphotodetector type (Cesium Iodide - CsI or Gadolinium Oxysulfide - GOS). It is compatible with Agfa's computed radoigraphy systems as well.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Agfa DR 600, a stationary X-ray system. The core of this submission is to demonstrate substantial equivalence to previously cleared devices, not to demonstrate clinical efficacy or a specific performance benchmark for an AI model.

Therefore, the acceptance criteria and study proving an AI device meets those criteria, as typically understood in Machine Learning or AI product development, are not explicitly present in this document. The document focuses on demonstrating that the DR 600, as an imaging system, performs equivalently to its predicates based on physical and technological characteristics, and that its image quality is comparable.

However, I can extract the closest analogous information to the requested points, interpreting "acceptance criteria" through the lens of demonstrating "substantial equivalence" and "device performance" in terms of physical and image quality comparisons.

Here's how the document addresses the spirit of your request, adapted for a medical imaging device without a specific AI component being evaluated for a diagnostic task:

Acceptance Criteria and Study for Agfa DR 600 (Interpreted for a Standard X-Ray System)

The primary "acceptance criterion" for this 510(k) submission is demonstrating substantial equivalence to legally marketed predicate devices. This means proving that the DR 600 is as safe and effective as the predicate devices and does not raise different questions of safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence claim for an X-ray system, the "acceptance criteria" are implied by comparing the new device's technical specifications and image quality to well-established predicates. No numerical "performance metrics" in the typical AI sense (e.g., AUC, sensitivity, specificity) for a diagnostic task are provided, as the device itself is the imaging system, not a diagnostic algorithm.

Parameter/Characteristic	Acceptance Criteria (Implied by Predicates)	Reported DR 600 Performance
Image Quality	Equivalent to or better than predicate devices (DR 400 & DX-M) based on visual assessment by qualified radiologists. No artifacts influencing image quality.	Laboratory image quality comparison of DR 600 (with flat-panel & CR cassettes) and DR 400 (predicate K141192) and DX-M (CR System) anthropomorphic phantoms were performed. "The study confirmed that the Agfa DR 600 system... was equivalent to or better in performance than the DR 400 and DX-M." No artifacts detected using DR 600 that could influence image quality.
Usability & Functionality	Supports radiographic workflow, design, functionality, and usability within a hospital environment. FLFS workflow rated positive. Fulfilled intended use.	Usability and functionality evaluations conducted. "The results of the usability test fell within the acceptance criteria for all components; therefore, the DR 600 supports a radiographic workflow. The usability and functionality of Full Leg Full Spine (FLFS) workflow for DR was rated positive as well. The intended use is fulfilled using different flat-panel detectors."
Grid Tests Consistency	Consistent with predicate DR 400 results. Varian (DX-D 10) and Vieworks (DX-D 40) detectors work well.	Flat field, chest, and skull phantoms created using all grids for DR 600. "The results of the grid tests remained consistent with the DR 400 (predicate K141192) results. The Varian (DX-D 10) and Vieworks (DX-D 40) detectors worked well and had positive results. The intended use is fulfilled using different flat-panel detectors and/or CR cassettes and plates."
Technological Characteristics	"Same" or "similar" to predicates for key components (e.g., communication, detector material, pixel size, dynamic range, workstation, image processing).	"Principles of operation and technological characteristics of the new and predicate devices are the same." (Detailed comparisons in pages 6-7). Minor differences like ceiling vs. floor mounted tube, and specific generator/tube models, are deemed not to alter intended diagnostic effect.
Regulatory Compliance	Meets relevant safety and performance standards (e.g., IEC 60601 series, ISO 14971, ISO 13485).	Compliance demonstrated through laboratory testing and software verification/validation against standards such as IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-54, ACR/NEMA PS3.1-3.20 (DICOM), ISO 14971, ISO 13485 (Page 8).
Risk Assessment	Risks are broadly acceptable or ALARP (As Low As Reasonably Practicable), with zero in the "Not Acceptable Region."	"For the DR 600 there are a total of 97 risks in the broadly acceptable region and eight risks in the ALARP region. Zero risks were identified in the Not Acceptable Region." (Page 8).

2. Sample Size and Data Provenance for Test Set

Sample Size: The document mentions "anthropomorphic phantoms" for image quality comparison and "all grids" for grid tests. It does not specify a specific number of phantom images or actual patient data. For usability, "qualified independent radiographers" and "qualified internal radiographer" participated.
Data Provenance: The data appears to be prospective laboratory testing using phantoms rather than retrospective patient data. The country of origin for the data is not specified but would presumably be Agfa's testing facilities (likely in Belgium or the US, given the submission details).

3. Number of Experts and Qualifications for Ground Truth

Number of Experts:
- Image Quality: "Qualified independent radiologists" (plural, so at least two).
- Usability & Functionality: "Qualified independent radiographers" (plural, so at least two).
- Grid Tests: "Qualified internal radiographer" (singular, presumably one).
Qualifications: "Qualified" is a general term. Specific years of experience or board certifications are not provided in this document.

4. Adjudication Method for the Test Set

Image Quality: "Performed in pairs by the qualified independent radiologists." This suggests a consensus or comparison method, possibly side-by-side. The specific adjudication rule (e.g., majority vote, forced consensus) is not detailed.
Usability & Functionality / Grid Tests: No specific adjudication method is mentioned beyond the conduct of the studies by qualified individuals.

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

No, an MRMC comparative effectiveness study was not done in the context of human readers improving with AI vs. without AI assistance. This document describes an X-ray imaging system, not an AI software intended for diagnostic assistance. The "image quality evaluations conducted with independent radiologists" were for demonstrating primary image quality equivalence, not for evaluating radiologist performance with or without an AI.

6. Standalone Performance (Algorithm Only)

Not applicable in the context of an AI algorithm. This device is a complete X-ray imaging system. Its performance (image quality, technical specifications) is evaluated as a standalone product. The "laboratory image quality comparison" can be considered as the "algorithm only" type of evaluation in the sense that the system's output (images) were assessed directly.

7. Type of Ground Truth Used

For image quality, the ground truth appears to be expert visual consensus/comparison on anthropomorphic phantom images.
For usability and functionality, the ground truth is based on user feedback and assessment against predefined usability criteria.
For grid tests, the ground truth is the consistency of the results with predicate device expectations and visual assessment by an expert.
No pathology or outcomes data were used as ground truth, as this is a technical equivalence submission for an imaging device, not a diagnostic AI.

8. Sample Size for the Training Set

Not applicable. This document describes a medical device, not a machine learning model. There is no concept of a "training set" for the DR 600 system itself. Its internal image processing (MUSICA2™) is mentioned as being identical to that used in the predicate devices, implying it's a pre-existing, validated algorithm rather than one trained specifically for this submission.

9. How Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for the DR 600 as a whole, this question is not addressed. The MUSICA2™ image processing is a pre-existing component validated with prior devices.

Summary: This 510(k) submission successfully demonstrates substantial equivalence of the DR 600 to its predicate devices through rigorous bench testing, including technical specifications comparison, image quality evaluation with phantoms by qualified radiologists, usability studies, and compliance with relevant safety and performance standards. The evaluations performed align with the requirements for showing that a new hardware medical imaging device is functionally and safely comparable to existing ones, rather than testing a novel AI diagnostic algorithm.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them.

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

December 11, 2015

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

Re: K152639

Trade/Device Name: DR 600 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: November 23, 2015 Received: November 24, 2015

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,

Robert Ocks

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)

K152639

Device Name

DR 600

Indications for Use (Describe)

The DR 600 is not intended for use in Mammography applications.

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:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"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)

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510(K) SUMMARY Agfa Digital Radiography (DR) Systems with DR 600

SUBMITTER I.

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

Contact: Koen Vervoort, Prepared: September 14, 2015 Telephone: +32-34444-7368

II. DEVICE

Name of Device: DR 600 Common Name: Solid State X-Ray Imager (Flat Panel/Digital Imager) Classification Name: Stationary X-Rav System Regulatory Classification: Class II, 21 CFR 892.1680 Product Code: MQB

III. PREDICATE DEVICES

This is a 510(k) for Agfa's DR 600, a solid state x-ray imaging device. It is substantially equivalent to systems with Agfa's DX-D 600 (K112670) and DR 400 (K141192).

These predicates have not been subject to a design-related recall. No reference devices were used in this submission.

DEVICE DESCRIPTION IV.

This submission is to add the DR 600 to Agfa's direct radiology portfolio.

Principles of operation and technological characteristics of the new and predicate devices are the same. The new device is physically and electronically identical to the predicate K112670 and virtually identical to predicate K141192 with the exception that it is has a ceiling mounted tube instead of floor mounted tube. It uses the same workstation and similar scintillator-photodetector

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flat panel detectors to capture and digitize the image.

The optional image processing allows users to conveniently select image processing settings for different patient sizes and examinations. The image processing algorithms in the new device are identical to those used in the predicates (K141192 & K112670).

Detectors

DR 600 includes the option of using one of three detectors; DX-D 10, DX-D 20, and DX-D 40. Each of these detectors are flat-panel scintillator-photodetectors (size 43x 35cm/ 14x17in) with a choice of either Cesium Iodide (Csl) or Gadolinium Oxy-Sulphide (GOS) detector conversion screens. The DX-D 10 and DX-D 20 detectors are both tethered; however, the DX-D 20 detector has a handle. The DX-D 40 detector is an instant detector with automatic exposure detection (AED) and wireless technology. A table further explaining the detector performance characteristics is on the next page.

PerformanceCharacteristics	DX-D 10 Flat-PanelDetector	DX-D 20 Flat-PanelDetector (Handle)	DX-D 40 Flat-PanelInstant Detector
Scintillator	CsI, GOS	CsI, GOS	CsI, GOS
Cassette size	35x43cm/14x17in	35x43cm/14x17in	35x43cm/14x17in
Pixel Size	139 μm	139 μm	140 μm
Nyquist Frequency	3.6 lp/mm	3.6 lp/mm	3.6 lp/mm
A/D Conversion	14 bits	14 bits	14 bits
Interface to Generator	Ethernet	Ethernet	AED & Synchronized
Communication	Tethered	Tethered	Wireless
Power	I/O Interface Box: 100-240 VAC, 47-63 Hz	I/O Interface Box: 100-240 VAC, 47-63 Hz	Battery: replaceable & rechargeable
Weight	3.9 kg (8.6 lbs)	4.9 kg (10.8 lbs)	3.4 kg (7.5 lbs)
DQE (G/C)	1lp/mm - 0.530/0.608;2lp/mm - 0.219/0.298;3lp/mm - 0.092/0.147	1lp/mm - 0.530/0.608;2lp/mm - 0.219/0.298;3lp/mm - 0.092/0.147	1lp/mm - 0.38/0.40;2lp/mm - 0.23/0.24;3lp/mm - 0.13/0.11
MTF (G/C)	1lp/mm - 0.205/0.456;2lp/mm - 0.106/0.304;3lp/mm - 0.092/0.147	1lp/mm - 0.205/0.456;2lp/mm - 0.106/0.304;3lp/mm - 0.092/0.147	1lp/mm - 0.570/0.578;2lp/mm - 0.269/0.279;3lp/mm - 0.142/0.150

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

V. INDICATIONS FOR USE

The DR 600 is not intended for use in Mammography applications.

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COMPARISON OF TECHNOLOGICAL CHARATERISTICS WITH VI. PREDICATE DEVICES

Agfa's DR 600 The new device and the DR 400 predicate device (K141192) are solid state imaging devices. Product Code MOB. Agfa's DR 600 is substantially equivalent to both predicate devices (K141192 & K112670) in that it uses precisely the same technology to capture and transmit images. The new device is a combination of a conventional x-ray system with digital image capture. The DR 600 is a ceiling mounted tube and operator console with a motorized patient table and/or wall stand. The DR 600 uses the same NX workstation with MUSICA 2 TM image processing and flat-panel detectors of the scintillator-photodetector type (Cesium Iodide -CsI or Gadolinium Oxysulfide - GOS) as both predicates (K141192 & K112670). It is compatible with Agfa's computed radoigraphy systems as well.

Performance data including laboratory image quality measurements and image comparison studies by independent radiologists are adequate to ensure equivalence.

Agfa's DR 600 has an Indications For Use statement identical to both predicate devices (K141192 & K112670). Intended uses are the same. The devices have the same technological characteristics.

The DR 600 indications for use is equivalent to predicates (K141192 & K112670) because all three include the delineation of anatomical areas and patient positions for the imaging applications. The DR 600 and predicate devices (K141192 & K112670) include the statement that the device is not indicated for mammography; however, predicate K112670 is not indicated for pediatric and neonatal patient populations. Differences in devices do not alter the intended diagnostic effect.

The table on the next page compares these technological charateristics.

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Agfa HealthCare NV Premarket Notification: Digital Radiography (DR) Systems with DR 600

	DR 600(New Device)	DR 400(PREDICATE -K141192)	AGFA DX-D 600(PREDICATE-K112670)
Communications	Same as predicates	DICOM	DICOM
Flat Panel or Image Plate	Same as predicates	Flat Panel Detector	Flat Panel Detector
Detector Material	Same as predicates	Gadolinium Oxysulfide(GOS) or Cesium Iodide(CsI) scintillator	Gadolinium Oxysulfide (GOS)or Cesium Iodide (CsI)scintillator
Detector Sizes	14x17 in.	17x17 in.14x17 in.	17x17 in.14x17 in.
Active Matrix (14x17 in.)	Same as predicate K112670	2560 x 3072	2560 x 30723070 x 3072
Pixel size	Same as predicates	139 µm	139 µm
Dynamic Range	Same as predicates	14 bit	14 bit DR, 12 bit CR
Maximum ImageAcquisitions/hr.	Same as predicates	150	150
Power Supply	Same as predicate K112670	50-60 Hz100-240V auto ranging	50-60 Hz380/400/415/440/480V ± 10%
Operator Workstation	Same as predicates	Agfa NX	Agfa NX
Image processing	Same as predicates	MUSICA, MUSICA2	MUSICA2
Generators	Choice of three models:50-80 KW	Choice of four models:40-80 KW	Choice of four models:32-80 KW
Tubes	Same as predicates	Toshiba models: E7252X,E7254FX, E7869X, &E7884X	Toshiba models: E7252X,E7254FX, E7869X, & E7884X
Operating system	Same as predicate K141192	Windows 7	Windows XP Pro
Display System	Same as predicates	Separately cleared medicaldisplay (K051901)	Separately cleared medicaldisplay (K051901)
Indications for UseStatements	DR 600 system is a GenRad X-Ray imaging system used inhospitals, clinics and medicalpractices by physicians,radiographers and radiologiststo make, process, and viewstatic X-Ray radiographicimages of the skeleton(including skull, spinal columnand extremities), chest,abdomen and other body partson adult and pediatric patients.Applications can be perfomedwith the patient in the sitting.standing or lying position.DR 600 is not indicated foruse in mammography	DR 400 system is a GenRadX-Ray imaging system usedin hospitals, clinics andmedical practices byphysicians, radiographers andradiologists to make, process,and view static X-Rayradiographic images of theskeleton (including skull,spinal column andextremities), chest, abdomenand other body parts on adultand pediatric patients.Applications can be perfomedwith the patient in the sitting,standing or lying position.DR 400 is not indicated foruse in mammography	DX-D 600 system is indicatedto make static X-Rayradiographic images of theskeleton (including skull,spinal column and extremities),chest, abdomen and other bodyparts.Applications can be perfomedwith the patient in the sitting,standing or lying position.This device is not intended foruse in mammography

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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 and imaging plates was evaluated by qualified individuals employed by the sponsor to demonstrate that adequate design controls (according to 21 CFR 820.30) were in place.

The following performance data are provided in support of the substantial equivalence determination.

Bench Testing

Image quality measurement data, performance/functionality data, grid tests, and usability data has been provided. No patient treatment was provided or withheld. No clinical or animal testing was performed in the development of the DR 600.

. Laboratory image quality comparison of the DR 600 and DR 400 (predicate K141192) and DX-M (CR System) anthropomorhic phantoms were performed in pairs by the qualified independent radiologists. There were no artifacts detected using the DR 600 system that could influence image quality. Both systems used MUSICA for image processing on the NX workstation. The study confirmed that the Agfa DR 600 system with the flat-panel detector and CR cassettes and plates was equivalent to or better in performance than the DR 400 and DX-M.
Usability and functionality evaluations were conducted with qualified independent ● radiographers. The study evaluated Agfa's DR 600 system regarding design, functionality, and usability within a hospital environment. The results of the usability test fell within the acceptance criteria for all components; therefore, the DR 600 supports a radiographic workflow. The usability and functionality of Full Leg Full Spine (FLFS) workflow for DR was rated positive as well. The intended use if fulfilled using different flat-panel detectors.
Grid Tests were conducted with a qualified internal radiographer. The study evaluated flat ● field, chest and skull phantoms created using all grids defined for the DR 600 system. The results of the grid tests remained consistent with the DR 400 (predicate K141192) results. The Varian (DX-D 10) and Vieworks (DX-D 40) detectors worked well and had positive results. The intended use if fulfilled using different flat-panel detectors and/or CR cassettes and plates.

Software Verification and Validation Testing

Verification and validation plans comprise of test protocols. The complete device has been cerified 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 600 there are a total of 97 risks in the broadly acceptable region and eight risks in the ALARP region. 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

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The 21 residual risks in the ALARP region for the released NX software versions NX8900 (NX Juno) are not greater than the risks of a conventional x-ray machine. The 81 risks identified in the Broadly Acceptable Region are in zone A and B. Therefore, the device is regarded as safe and the benefits of the device outweigh the residual risk.

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 device has been determined to be moderate.

Electrical Safety and Electromagnetic Compatibility (EMC) Testing:

ACR/NEMA PS3.1-3.20: 2011 Digital Imaging and Communications in Medicine (DICOM). .
IEC 60601-1: 2012 Medical Electrical Equipment: General Requirements for Safety and Essential . Performance.
IEC 60601-1-2: 2007 Medical Electrical Equipment - Part 1-2: General Requirements for Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests.
IEC 60601-1-3: 2008 Medical Electrical Equipment Part 1-3: General Requirements for Safety and . Essential Performance - Collateral Standard: Radiation Protection in Diagnostic X-Ray Equipment
. IEC 60601-2-28: 2010 Medical Electrical Equipment - Part 2-28: Particular Requirements for the Basic Safety and Essential Performance of X-Ray Tube Assemblies for Medical Diagnosis.
IEC 60601-2-54: 2009 Medical Electrical Equipment Part 2-54: Particular Requirements for the . Basic Safety and Essential Performance of X-Ray Equipment for Radiography and Radioscopy.
ISO 14971:2012 Application of Risk Management to Medical Devices
ISO 13485:2012 Medical Devices Quality Management Systems Requirements For Regulatory ● purposes

Summary

Based on the performance data as documented in the above testing, the DR 600 is found to have a safety and effectiveness profile that is similar to the predicate devices.

VIII. CONCLUSIONS

Agfa's DR 600 has an Indications For Use statement identical to both predicate devices (K141192 & K112670). Intended uses are the same. The devices have the same technological characteristics.

The new device and the DR 400 predicate device (K141192) are solid state imaging devices,

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Product Code MQB. Agfa's DR 600 is substantially equivalent to both predicate devices (K141192 & K112670) in that it uses precisely the same technology to capture and transmit images.

There are no changes to the intended use/indications of the device. The DR 600 uses the same NX workstation and similar detectors as both predicates (K141192 & K112670).

Differences in devices do not alter the intended diagnostic effect. Performance data including laboratory image quality measurements and image comparison studies by independent radiologists are adequate to ensure equivalence.

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.