(87 days)
Not Found
No
The document mentions "MUSICA2 ™ image processing" but does not provide any details suggesting the use of AI or ML algorithms within this processing. There is no mention of AI, DNN, or ML, nor are there descriptions of training or test sets typically associated with AI/ML development. The performance studies focus on image quality, usability, and safety, not on the performance metrics (like sensitivity, specificity, AUC) commonly used to evaluate AI/ML-based diagnostic or analytical devices.
No
Explanation: This device is described as an X-ray imaging system used to make, process, and view static X-ray radiographic images. Its purpose is diagnostic imaging, not therapeutic intervention or treatment.
Yes
Explanation: The DR 600 is an X-ray imaging system used to make and view static X-ray radiographic images of various body parts. These images are then used by medical professionals (radiographers, radiologists, and physicists) to assess and understand the internal structures of patients, which is a key step in diagnosing medical conditions.
No
The device description explicitly states it is a "solid state x-ray system, a direct radiography (DR) system" and includes hardware components like a ceiling mounted tube, operator console, motorized patient table, wall stand, and flat-panel detectors.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an X-ray imaging system used to make, process, and view static X-ray radiographic images of the human body. This involves imaging the internal structures of the body directly, not analyzing samples taken from the body (like blood, urine, or tissue).
- Device Description: The description confirms it's a solid state x-ray system that captures images of the human body.
- Input Imaging Modality: The input is X-ray radiographic images, which are generated by passing X-rays through the body.
- Anatomical Site: The device images specific anatomical sites within the body.
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
The DR 600 is a medical imaging device used for diagnostic purposes, but it falls under the category of in vivo imaging (imaging within the living body), not in vitro diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes
MQB
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 TM 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.
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 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).
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
skeleton (including skull, spinal column and extremities), chest, abdomen and and other body parts
Indicated Patient Age Range
adults and pediatric patients
Intended User / Care Setting
radiographers, radiologists and physicists; hospitals, clinics and medical practices
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Testing:
- Study type: Laboratory image quality comparison.
- Sample size: Anthropomorphic phantoms.
- Data source: Not specified as patient data.
- Annotation protocol: Image analysis by qualified independent radiologists.
- Key results: 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:
- Study type: Usability and functionality evaluation.
- Sample size: Not specified, but involved qualified independent radiographers.
- Data source: Not specified as patient data.
- Annotation protocol: Not specified.
- Key results: 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:
- Study type: Grid tests.
- Sample size: Not specified, but involved a qualified internal radiographer. Phantom images were used (flat field, chest, skull).
- Data source: Not specified as patient data.
- Annotation protocol: Not specified.
- Key results: 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:
- Study type: Verification and Validation.
- Sample size: Not specified.
- Data source: Not specified as patient data.
- Annotation protocol: Not specified.
- Key results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
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
2
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)
Device Name
DR 600
Indications for Use (Describe)
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.
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.
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.
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
4
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.
| Performance
Characteristics | DX-D 10 Flat-Panel
Detector | DX-D 20 Flat-Panel
Detector (Handle) | DX-D 40 Flat-Panel
Instant 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 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.
5
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.
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 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).
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.
6
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 3072
3070 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 Image
Acquisitions/hr. | Same as predicates | 150 | 150 |
| Power Supply | Same as predicate K112670 | 50-60 Hz
100-240V auto ranging | 50-60 Hz
380/400/415/440/480V ± 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 medical
display (K051901) | Separately cleared medical
display (K051901) |
| Indications for Use
Statements | 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 | DR 400 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 400 is not indicated for
use in mammography | DX-D 600 system is indicated
to make static X-Ray
radiographic images of the
skeleton (including skull,
spinal column and extremities),
chest, abdomen and other body
parts.
Applications can be perfomed
with the patient in the sitting,
standing or lying position.
This device is not intended for
use 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
8
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 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 new device and the DR 400 predicate device (K141192) are solid state imaging devices,
9
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.