Who is the manufacturer of DR 600 with Tomosynthesis?

Agfa N.V. filed the 510(k) submission for DR 600 with Tomosynthesis (K193262).

What is the FDA product code for DR 600 with Tomosynthesis?

IZF. It is classified under 21 CFR 892.1740 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for DR 600 with Tomosynthesis?

510(k) clearance (submission type: Traditional).

What are the predicate devices for DR 600 with Tomosynthesis?

DR 800 with Tomosynthesis (K183275); DR 600 (K152639).

Who can help prepare an FDA 510(k) submission like DR 600 with Tomosynthesis?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

DR 600 with Tomosynthesis

K193262 · Agfa N.V. · IZF · Mar 9, 2020 · Radiology

Device Facts

Record ID	K193262
Device Name	DR 600 with Tomosynthesis
Applicant	Agfa N.V.
Product Code	IZF · Radiology
Decision Date	Mar 9, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1740
Device Class	Class 2
Attributes	Pediatric

Intended Use

The DR 600 system is a General Radiography 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 adult, pediatric or neonatal patients. In addition, the system provides the Agfa tomosynthesis option, which is intended to acquire tomographic slices of human anatomy and to be used with Agfa DR X-ray systems. Digital tomosynthesis is used to synthesize tomographic slices from a single tomographic sweep. Applications can be performed with the patient in the sitting, standing or lying position. This system is not intended for mammography applications.

Device Story

Ceiling-mounted tomographic and general radiographic X-ray system; consists of tube, operator console, motorized patient table, and wall stand. Uses flat-panel detectors (CsI or GOS scintillator-photodetector) to capture X-ray signals. Operates via Agfa NX workstation with MUSICA2 and MUSICA DTS (Digital TomoSynthesis) software. Used in hospitals/clinics by radiographers, radiologists, and physicists. Captures static images and tomographic slices from a single sweep. Output viewed on medical displays to assist in diagnostic decision-making. Benefits include high-quality radiographic imaging and tomographic slice synthesis for improved anatomical visualization. System supports sitting, standing, or lying patient positions.

Clinical Evidence

No clinical trials or animal studies performed. Bench testing only. Image quality evaluations compared anthropomorphic adult and pediatric images against primary predicate (DR 800). Results confirmed performance, functionality, and usability met acceptance criteria and were equivalent to predicates.

Technological Characteristics

Ceiling-mounted X-ray system; flat-panel detectors (CsI or GOS scintillator); 16-bit dynamic range; 148 µm pixel size. Connectivity via DICOM. Software includes MUSICA2, MUSICA3/3+, and MUSICA DTS. Compliant with IEC 60601-1, 60601-1-2, 60601-1-3, 60601-1-6, 60601-2-28, 60601-2-54, and 21 CFR 1020.30/31.

Indications for Use

Indicated for general radiography X-ray imaging of the skeleton, chest, abdomen, and other body parts in adult, pediatric, and neonatal patients. Includes tomosynthesis option for acquiring tomographic slices of human anatomy. Not indicated for mammography.

Regulatory Classification

Identification

A tomographic x-ray system is an x-ray device intended to be used to produce radiologic images of a specific cross-sectional plane of the body by blurring or eliminating detail from other planes. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

DR 800 with Tomosynthesis (K183275)
DR 600 (K152639)

Reference Devices

DR 14s (K161368)
DR 14e/17e (K172784)
DX-D 40/45/60 (K142184)
DX-D 100 (K103597)
DX-D 300 (K103050)
DX-D 600 (K112670)
DR 400 (K141192)
Medical display (K051901)

Related Devices

K183275 — DR 800 with Tomosynthesis · Agfa N.V. · Feb 1, 2019
K212145 — DR 800 with DSA, DR 800 · Agfa N.V. · Aug 31, 2021
K152244 — RADspeed Pro · Shimadzu Corporation · Jun 20, 2016
K112670 — DX-D 600 · Agfa Healthcare N.V. · Oct 27, 2011
K142341 — X-RAY TV SYSTEM SONIALVISION G4 · Shimadzu Corp. · Mar 6, 2015

Submission Summary (Full Text)

{0}------------------------------------------------ March 9, 2020 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo 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. Agfa N.V. % Ms. ShaeAnn Cavanagh Regulatory Affairs Manager, North America Agfa US Corp. 10 South Academy Street GREENVILLE SC 29601 Re: K193262 Trade/Device Name: DR 600 with Tomosynthesis Regulation Number: 21 CFR 892.1740 Regulation Name: Tomographic x-ray system Regulatory Class: Class II Product Code: IZF, MQB Dated: February 7, 2020 Received: February 10, 2020 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. For Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K193262 Device Name DR 600 with Tomosynthesis #### Indications for Use (Describe) The DR 600 system is a General Radiography 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 adult, pediatric or neonatal patients. In addition, the system provides the Agfa tomosynthesis option, which is intended to acquire tomographic slices of human anatomy and to be used with Agfa DR X-ray systems. Digital tomosynthesis is used to synthesize tomographic slices from a single tomographic sweep. Applications can be performed with the patient in the sitting, standing or lying position. This system is not intended for 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) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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." {3}------------------------------------------------ # 510(K) SUMMARY ### Agfa N.V. DR 600 with Tomosynthesis #### SUBMITTER I. Agfa N.V. Septestraat 27 B-2640 Mortsel Belgium Contact: Wim Govaerts, Prepared: November 26, 2019 Telephone: + 32 3444 6246 #### DEVICE II. Name of Device: DR 600 with Tomosynthesis Common Name: System, X-Ray, Tomographic Classification Name: Tomographic X-ray System Regulatory Classification: Class II, 21 CFR 892.1740 Product Code: IZF #### III. PREDICATE DEVICES This is a 510(k) for Agfa's DR 600 with Tomosynthesis which is a tomographic and solid state xray system. It is substantially equivalent to both of Agfa's predicate devices, DR 800 with Tomosynthesis (primary - K183275) and DR 600 (K152639). Primary Predicate Device: DR 800 with Tomosynthesis Common Name: System, X-Ray, Tomographic Classification Name: Tomographic X-ray System Regulatory Classification: Class II, 21 CFR 892.1740 Product Code: IZF Predicate Device: DR 600 Common Name: Solid State X-Ray Imager (Flat Panel/Digital Imager) Classification Name: Stationary X-Ray System Regulatory Classification: Class II, 21 CFR 892.1680 Product Code: MQB Neither the DR 800 with Tomosynthesis (K183275) primary predicate device nor the DR 600 (K152639) predicate device has not been subject to a design-related recall. {4}------------------------------------------------ #### IV. DEVICE DESCRIPTION The DR 600 with Tomosynthesis is a tomographic and solid state x-ray system (product codes IZF and MQB) intended to capture tomographic slices and static images of the human body. The DR 600 with Tomosynthesis is a ceiling mounted tomographic and general radiographic system that consists of a tube and operator console with a motorized patient table and/or wall stand. The DR 600 with Tomosynthesis uses Agfa's NX workstation with MUSICA2 ™ image processing and flat-panel detectors of the scintillator-photodetector type (Cesium Iodide - CsI or Gadolinium Oxysulfide - GOS). It is capable of replacing other direct radiography, tomography, image intensifying tubes and TV cameras, including computed radiography systems with conventional or phosphorous film cassettes. This submission is to add the newest version of the DR 600 with Tomosynthesis to Agfa's radiography portfolio. 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 previously cleared in the DR 800 (K183275- primary) and DR 600 (K152639) predicate devices and other devices in Agfa's radiography portfolio today. The addition of the tomographic image processing is identical to the DR 800 (K183275) primary predicate device. Principles of operation and technological characteristics of the new and predicate devices are the same. The new device is virtually identical to Agfa's predicate DR 600 (K152639) with the exception that it has additional MUSICA Digital TomoSynthesis (DTS) software for processing tomographic slices. MUSICA DTS software is identical to the software in Agfa's predicate DR 800 with Tomosynthesis (K183275). It uses the same flat panel detectors to capture and digitize the image. Laboratory data and image quality evaluations conducted with internal and independent specialists confirm that performance is equivalent to the predicates. Differences in devices do not alter the intended diagnostic effect nor do they impact the safety and effectiveness of the device. Configuration information for the flat-panel detectors can be found in the DR 14s (K161368), DR 14e/17e (K172784), DX-D 40/45/60 (K142184) and DR 600 User Manuals. The DR 14s, DR 14e/17e, RF FL4343 and DX-D 40/45/60 detectors can be integrated in an X-ray system that communicates to a workstation. The Service Manual details the possible configurations and integrations with the NX workstation and X-ray generator. All of Agfa's DR X-ray systems (i.e. DX-D 100-K103597, DX-D 300-K103050, DX-D 600-K112670, DR 400-K141192, DR 600-K152639, DR 800-K183275) will integrate with the detectors. The NX Service Manual, Chapter 4 and associated appendices addresses the installation and configuration with other system components. #### V. INDICATIONS FOR USE The DR 600 system is a General Radiography X-ray imaging system used in hospitals, clinics and medical practices by radiographers, radiologists and physicists to make, process and view static Xray radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts on adult, pediatric or neonatal patients. {5}------------------------------------------------ In addition, the system provides the Agfa tomosynthesis option, which is intended to acquire tomographic slices of human anatomy and to be used with Agfa DR X-ray systems. Digital tomosynthesis is used to synthesize tomographic slices from a single tomographic sweep. Applications can be performed with the patient in the sitting, standing or lying position. This system is not intended for mammography applications. NOTE: The mammography applications embedded in the MUSICA software are for previously cleared CR imaging applications (K081963) and not intended for direct radiography (DR) imaging. Furthermore, the additional mammography software is only available through additional license keys that must be purchased. These license keys are only available outside of the USA. ## PEDIATRIC USE SUMMARY The DR 600 with Tomosynthesis is intended for general populations, including adult and pediatric patients of all ages. There are no specific pediatric and neonatal design features; however, the DR 600 with Tomosynthesis provides the following specific design features and instructions that enable safer use of the device with pediatric and neonatal patients: | Pediatric Imaging Design Features | Standard or Optional | |-----------------------------------|--------------------------------------------------------------------| | Protocols or exposure indices | Standard - make own exam tree optional - make use of age groups | | Filter and removable grid | Standard | | Collimator alignment | Standard | | Variable focal spot size | Standard | | Post-processing application | Standard/ no specific pediatric post processing for tomo | | Reconstruction algorithm | no specific pediatric reconstruction algorithm | #### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICES Agfa's DR 600 with Tomosynthesis and the DR 800 with Tomosynthesis primary predicate device (K183275) are tomographic x-ray systems, Product Code IZF. The new device and DR 600 predicate device (K152639) are solid state x-ray systems, Product Code MQB). Agfa's DR 600 with Tomosynthesis is substantially equivalent to both predicate devices (K183275 & K152639) in that it uses precisely the same technology to capture and transmit images. The complete DR 600 system consists of a stationary table, ceiling mounted suspension equipped with a collimator and tube housing assembly, integrated x-ray generator, NX MUSICA software and one or more DR flat-panel detectors. {6}------------------------------------------------ Principles of operation and technological characteristics of the new and predicate devices are the same. The new device is virtually identical to Agfa's predicate DR 600 (K152639) with the exception that it has additional MUSICA Digital TomoSynthesis (DTS) software for processing tomographic slices. MUSICA DTS software is identical to the software in Agfa's predicate DR 800 with Tomosynthesis (K183275). It uses the same flat panel detectors to capture and digitize the image. Laboratory data and image quality evaluations conducted with internal and independent specialists confirm that performance is equivalent to the predicates. Differences in devices do not alter the intended diagnostic effect nor do they impact the safety and effectiveness of the device. 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 previously cleared in the DR 800 (K183275- primary) and DR 600 (K152639) predicate devices and other devices in Agfa's radiography portfolio today. The addition of the tomographic image processing is identical to the DR 800 (K183275) primary predicate device. Agfa's DR 600 with Tomosynthesis has an Indications For Use statement virtually identical to predicate device (K152639) except it includes the addition of tomosynthesis. However, the tomosynthesis addition is identical to the statement in primary predicate device (K183275). Intended uses are the same. The devices have the same technological characteristics. The DR 600 with Tomosynthesis indications for use is equivalent to predicate (K152639) because both include the delineation of anatomical areas and primary predicate (K183275) includes imaging applications and the application of tomosynthesis. The DR 600 with Tomosythnesis and both predicate devices (K183275 and K152639) include the statement that the devices are not indicated for mammography. The new device and the DR 800 with Tomosynthesis primary predicate device (K183275) are tomographic x-ray systems, Product Code IZF. The new device and DR 600 predicate device (K152639) are solid state x-ray systems, Product Code MQB). Agfa's DR 600 with Tomosynthesis is substantially equivalent to both predicate devices (K183275 & K152639) in that it uses precisely the same technology to capture and transmit images. Descriptive characteristics and performance data including image quality evaluations by internal and external specialists are adequate to ensure equivalence. Table 2 on the next page summarizes the similarities and differences between the new device and predicates. {7}------------------------------------------------ | | DR 600 with Tomosynthesis (NEW DEVICE) | DR 800 with Tomosynthesis (PRIMARY PREDICATE) K183275 | DR 600 (PREDICATE) K152639 | |-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Communications | Same as both predicate | DICOM | DICOM | | Flat Panel Detectors | Same as both predicates | Flat Panel Detectors | Flat Panel Detectors | | Detector Material | Same as both predicates | Gadolinium Oxysulfide (GOS) or Cesium Iodide (CsI) Scintillator | Gadolinium Oxysulfide (GOS) or Cesium Iodide (CsI) Scintillator | | Detector Sizes | Same as both predicates | 17x17 in. 14 x 17 in 10 x 10 in | 14 x 17 in | | Pixel Size | Same as both predicates | 148 µm | 139 µm | | Dynamic Range | Same as both predicates | 16 bit | 14 bit | | Operator Workstation | Same as both predicates | Agfa NX | Agfa NX | | Image processing | MUSICA DTS MUSICA2 MUSICA3/3+ | MUSICA Dynamic MUSICA DTS MUSICA2 MUSICA3/3+ | MUSICA2 | | Operating System | Same as predicate K183275 | Windows 7, 8, 8.1, 10 | Windows XP Pro | | Display System | Same as both predicates | Separately cleared medical display (K051901) | Separately cleared medical display (K051901) | | Power Supply | Same as predicate K152639 | 50-60 Hz 100-240V auto ranging | 50-60 Hz 380/400/415/440/480V + 10% | | Generators | Same as predicate K183275 | Choice of three models: 50, 65KW, 80 KW | Choice of four models: 32-80 KW | | Indications for Use Statements | The DR 600 system is a General Radiography 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 adult, pediatric or neonatal patients. In addition, the system provides the Agfa tomosynthesis option, which is intended to acquire tomographic slices of human anatomy and to be used with Agfa DR X-ray systems. Digital tomosynthesis is used to synthesize tomographic slices from a single tomographic sweep. Applications can be performed with the patient in the sitting, standing or lying position. This device is not intended for mammography applications. | The DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following anatomies/procedures: Positioning fluoroscopy procedures, Gastro- intestinal examinations, Urogenital tract examinations, and Angiography. It is intended to replace fluoroscopic images obtained through intensifier technology. In addition, the system is intended for project radiography of all body parts. In addition, the system provides the Agfa Tomosynthesis option, which is intended to acquire tomographic slices of human anatomy and to be used with Agfa DR X-ray systems. Tomosyntheis is used to synthesize tomographic slices from a single tomographic sweep. The DR 800 is not intended for mammography applications. | DR 600 system is a GenRad X-Ray imaging system used in hospitals, clinics and medical practices by physicians, radiographers and radiologists 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 adult and pediatric patients. Applications can be perfomed with the patient in the sitting, standing or lying position. DR 600 is not indicated for use in mammography. | {8}------------------------------------------------ ## Table 1: Device Comparison Table #### VII. PERFORMANCE DATA Laboratory testing and software testing (for a moderate level of concern device) using equivalent test protocols were evaluated by qualified individuals to demonstrate that adequate design controls (according to 21 CFR 820.30) were in place. Verification and validation testing confirmed the device meets performance, safety, usability and security requirements. Pediatric indications were also taken into account. Results were verified and validated. No clinical trials were performed in the device. 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 evaluations for adults and pediatric patients, performance/functionality and usability data has been provided. - Technical and acceptance testing was completed on the DR 600 in order to confirm the medical device functions and performs as intended. All deviations or variances are documented in a defect database and addressed in the CRD documentation and verified. All mitigations have been tested and passed. All design input requirements have been tested and passed. All planned verification activities have been successfully completed. - functionality evaluations were conducted with three qualified . Usability and radiographers. The results of these tests fell within the acceptance criteria for the DR 600; therefore, the DR 600 supports a tomographic workflow and Smart Dr visualization including adult and pediatric patients. - Clinical image validation was conducted during testing in support for the 510(k) clearance ● for the flat-panel detectors (K161368, K172784 and K142184) in a previous premarket submission. Refer to these 510(k) clearances for full image quality validation testing for the detectors. Image quality bench tests were conducted in support of this 510(k) submission in which anthropomorphic adult and pediatric images taken with the DR 600 and the primary predicate device, DR 800 (K183275) were compared to ensure substantial equivalency. The test results indicated the image processing of the DR 600 passed the acceptance criteria and was equal to the image processing for the primary predicate, DR 800 (K183275) device for both adult and pediatric patients Performance data including clinical image quality evaluations for adults and pediatric patients, performance/functionality and usability data are adequate to ensure equivalence. ### Software Verification and Validation Testing {9}------------------------------------------------ Verification and validation plans comprise of test protocols. The complete device has 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. Software verification testing for Digital TomoSynthesis (DTS) was completed in scope of the DR 600 system. Four software iterations were tested. including the tube head and XRDi. HERDE defects were identified; however, they were solved between test execution and the completion of the final report and will be part of the next maintenance software release. For the NX22 (NX Nomad) software there are a total of 342 risks in the broadly acceptable region and 27 risks in the ALARP region with only one of these risks identified. 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. The software risk assessment is assessed on solution level for the DR 600 and also includes separate risk assessments for the NX 22 software and XRDi. 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 DR 600 with Tomosynthesis and NX 22 has been determined to be moderate. ## Electrical Safety and Electromagnetic Compatibility (EMC) Testing: - IEC 60601-1: 2012 Medical Electrical Equipment: General Requirements for Safety and Essential Performance. - IEC 60601-1-2: 2014 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 60601-1-6: 2010 Medical Electrical Equipment Part 1-6: General Requirements for . Safety and Essential Performance - Collateral Standard Usability - IEC 60601-2-28: 2010 Medical Electrical Equipment Part 2-28 Particular Requirements ● for 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. The DR 600 with Tomosynthesis is compliant to the FDA Subchapter J mandated performance standard 21 CFR 1020.30 and 1020.31. Agfa's in-house standard operating procedures were also used for the development of the device and software; these procedures conform to the following standards: - ISO 13485:2015 Medical Devices Quality Management Systems ● - ISO 14971:2012 Application of Risk Management to Medical Devices ● {10}------------------------------------------------ - ACR/NEMA PS3.1-3.20: 2011 Digital Imaging and Communications in Medicine (DICOM) . ## Guidance Documents Agfa utilized the following guidance documents in the development of the DR 600 with Tomosynthesis: - Guidance for the Content of Premarket Submissions for Software Contained in Medical ● Devices (May 2005) - . Cybersecurity for Networked Medical Devices Containing Off-The-Shelf (OTS) Software (January 2005) - Off-the-Shelf Software Use in Medical Devices (September 2019) ● - Content of Premarket Submissions for Management of Cybersecurity in Medical Devices ● (October 2018) - . Guidance for Pediatric Information for X-ray Imaging Device Premarket Notifications (November 2017) ### Summarv Based on the performance data as documented in the above testing, the DR 600 with Tomosynthesis is found to have a safety and effectiveness profile that is similar to the predicate device. #### VIII. CONCLUSIONS Agfa's DR 600 with Tomosynthesis has indications for use that is consistent with that of the legally marketed predicate devices (K183275 & K152639). Intended uses are the same. Laboratory tests conclude that the device is substantially equivalent to the predicates. Differences in devices do not alter the intended diagnostic effect nor do they impact the safety and effectiveness of the device. The new device and the DR 800 with Tomosynthesis primary predicate device (K183275) are tomographic x-ray systems, Product Code IZF. The new device and DR 600 predicate device (K152639) are solid state x-ray systems, Product Code MQB). Agfa's DR 600 with Tomosynthesis is substantially equivalent to both predicate devices (K183275 & K152639) in that it uses precisely the same technology to capture and transmit images. 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.