(127 days)
No
The document describes "MUSICA" image processing software, which is explicitly defined as "Multi-Stage-Image-Contrast-Amplification" and acts on images to enhance contrast. There is no mention of AI, ML, deep learning, neural networks, or any related concepts. The description focuses on traditional image processing techniques.
No
The device is an imaging system designed to capture diagnostic quality radiographic images, not to treat a condition or disease.
Yes
The "Intended Use / Indications for Use" section states that the device is "indicated for use in general projection radiographic applications to capture for display diagnostic quality radiographic images of human anatomy." This explicitly mentions its role in producing images for diagnosis.
No
The device description explicitly states it is a "direct radiography imaging system" that uses "flat panel detectors" and a "workstation," indicating it includes significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the Agfa DX-D Imaging Package is an imaging system that captures radiographic images of human anatomy using x-rays. It is used for general projection radiography.
- Lack of Biological Sample Analysis: There is no mention of the device analyzing biological samples or performing any tests on specimens taken from the body. Its function is to create visual images of internal structures.
Therefore, the device falls under the category of medical imaging equipment, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Agfa's DX-D Imaging Package is indicated for use in general projection radiographic applications to capture for display diagnostic quality radiographic images of human anatomy. The DX-D Imaging Package may be used wherever conventional screen-film systems may be used.
Agfa's DX-D Imaging Package is not indicated for use in mammography.
Product codes
MQB
Device Description
The device is a direct radiography imaging system of similar design and construction to the predicate. Agfa's DX-D Imaging Package uses the company's familiar NX workstation with MUSICA2 TM image processing and flat panel detectors of the scintillator-photodetector type. Flat panel detectors with scintillators of both Cesium Iodide (CsI) and Gadolinium Oxysulfide (GOS) are available. The device is used to capture and directly digitize x-ray images without a separate digitizer common to computed radiography systems. This new version uses a previously cleared detector with wireless communication capability.
The device uses a direct conversion process to convert x-rays into a digital signal. X-rays incident on the scintillator layer of the detector generate light that is absorbed by photo-detectors, converted to a digital signal and sent to the workstation the data is processed by Agfa's MUSICA image processing software. The acronym MUSICA stands for Multi-Stage-Image-Contrast-Amplification. MUSICA-acts on the acquired images to preferentially enhance the diagnostically relevant, moderate and subtle contrasts.
Principles of operation and technological characteristics of the new and predicate devices are the same.
Mentions image processing
Agfa's DX-D Imaging Package uses the company's familiar NX workstation with MUSICA2 TM image processing and flat panel detectors of the scintillator-photodetector type.
the data is processed by Agfa's MUSICA image processing software. The acronym MUSICA stands for Multi-Stage-Image-Contrast-Amplification. MUSICA-acts on the acquired images to preferentially enhance the diagnostically relevant, moderate and subtle contrasts.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
human anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Image quality measurements have been completed. Image quality comparisons between the new and predicate devices have been performed as well. Sample images have been provided.
Performance of the complete system has been validated.
No clinical testing was performed in the development of the DX-D Imaging Package.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
(12) 095
AUG 1 6 2012
5.510(K) Summary
510(K) SUMMARY: AGFA DX-D Imaging Package
Regulation Name: Image Intensified fluoroscopic x-ray system (21 CFR 892.1650) Classification Name: Solid state x-ray imager (flat panel/digital imager) (product code MQB) Common Name: Direct radiography system Proprietary Name: DX-D Imaging Package Agfa HealthCare N.V. Septestraat 27 B-2640 Mortsel Belgium Contact: Phil Cuscuna. Prepared: January 15, 2012 Telephone: (416) 240-7317 Facsimile: (416) 240-7359
LEGALLY MARKETED PREDICATE DEVICES A.
This is a 510(k) for the latest version of Agfa's DX-D Imaging Package, a solid state, flat-panel x-ray imaging system.
B. DEVICE DESCRIPTION
The device is a direct radiography imaging system of similar design and construction to the predicate. Agfa's DX-D Imaging Package uses the company's familiar NX workstation with MUSICA2 TM image processing and flat panel detectors of the scintillator-photodetector type. Flat panel detectors with scintillators of both Cesium lodide (Csl) and Gadolinium Oxysulfide (GOS) are available. The device is used to capture and directly digitize x-ray images without a separate digitizer common to computed radiography systems. This new version uses a previously cleared detector with wireless communication capability.
The device uses a direct conversion process to convert x-rays into a digital signal. X-rays incident on the scintillator layer of the detector generate light that is absorbed by photo-detectors, converted to a digital signal and sent to the workstation the data is processed by Agfa's MUSICA image processing software. The acronym MUSICA stands for Multi-Stage-Image-Contrast-Amplification. MUSICA-acts on the acquired images to preferentially enhance the diagnostically relevant, moderate and subtle contrasts.
Principles of operation and technological characteristics of the new and predicate devices are the same.
ﺰ INTENDED USE
Agfa's DX-D Imaging Package is indicated for use in general projection radiographic applications to capture for display diagnostic quality radiographic images of human anatomy. The
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DX-D Imaging Package may be used wherever conventional screen-film systems may be used.
Agfa's DX-D Imaging Package is not indicated for use in mammography.
SUBSTANTIAL EQUIVALENCE SUMMARY D.
Agfa's DX-D Imaging Package has an Indications For Use statement similar to the statements for the predicate device, K092669. Intended uses are the same. The devices have the same technological characteristics. Descriptive characteristics and performance data are adequate to ensure equivalence.
The device does not have therapeutic effects. Differences in new device and the predicate do not alter the intended diagnostic effect.
| PRODUCT COMPARISON TABLE | ||
|---|---|---|
| DX-D Imaging Package | ||
| (New Device) | AGFA DX-D Imaging Package | |
| (PREDICATE-K092669) | ||
| Communications | DICOM | DICOM |
| Flat Panel | ||
| Manufacturer | Varian Medical Systems (wired detectors) | |
| Canon (wireless detector) | Varian Medical Systems | |
| Detector Material | Varian: Gadolinium Oxysulfide (GOS), or | |
| Varian & Canon: Cesium Iodide (CSI) | Gadolinium Oxysulfide (GOS) or | |
| Cesium Iodide (CSI) scintillator | ||
| Detector Sizes | 17x17 in. | |
| 14x17 in. | 17x17 in. | |
| 14x17 in. | ||
| Active Matrix | ||
| (14x17 in.) | 2560x3072 (Varian) | |
| 2800x3408 (Canon) | 2560x3072 | |
| Pixel size | 139 um (Varian), or | |
| 125 um (Canon) | 139 um | |
| Dynamic Range | 14 bit | 14 bit |
| Maximum Image | ||
| Acquisitions/hr. | 150 | 1 20 |
| Power Supply | 47-63 Hz | |
| 90-264V auto ranging | 47-63 Hz | |
| 90-264V auto ranging | ||
| Operator | ||
| Workstation | Agfa NX | Agfa NX |
| Image processing | MUSICA2 | MUSICA- |
| Operating system | Windows 7 | Windows XP Pro |
| Display System | Standard PC display or separately cleared | |
| medical display (e.g. K051901) | Standard PC display or separately | |
| cleared medical display (e.g. K051901) |
2
TECHNOLOGICAL CHARACTERISTICS E.
Agfa's DX-D Imaging Package is a scintillator-photodetector type solid state x-ray imaging system. The device provides the user with a choice of three wired or wireless flat panel detectors to capture and digitized the image. A computer workstation allows users view and process images, and forward them to other devices (e.g. a PACS or printer).
The DX-D Imaging Package is integrated with compatible x-ray systems.
TESTING F.
Image quality measurements have been completed. Image quality comparisons between the new and predicate devices have been performed as well. Sample images have been provided.
Performance of the complete system has been validated.
No clinical testing was performed in the development of the DX-D Imaging Package.
The product, manufacturing and development processes have been shown to conform to product safety, radiology, and imaging standards including:
PRODUCT STANDARDS
- IEC 60601-1: Medical electrical equipment Part 1: General requirements for basic safety and essential . performance, plus collateral standard: Electromagnetic compatibility - requirements and tests.
- . IEC 60601-1-2: Medical electrical equipment - Part 1-2: General Requirements For Safety - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests
- ACR/NEMA PS3.1-3.18: Digital Imaging and Communications in Medicine (DICOM) .
MANAGEMENT STANDARDS
- ISO 14971 Application of Risk Management to Medical Devices .
- ISO 13485 Medical Devices Quality Management Systems Requirements For Regulatory purposes .
CONCLUSIONS G.
This 510(k) has demonstrated Substantial Equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure with three stylized wing or feather shapes.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
AUG 16 2012
Agfa Healthcare N.V. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K121095
Trade/Device Name: DX-D Imaging Package . Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: MQB Dated: April 24, 2012 Received: April 25, 2012
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becally of 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 coninered phor to 112) 20, 2017 11:11 accordance with the provisions of the Federal Food, DNIg, devices that have occh recuired in accee approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The 1 ou may, therefore, thanks of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such If your device is classified (boo aco regulations affecting your device can be found in Title 21, additional controls. Existing mayor regulation, 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 Ficase oe advised that I Dri 3 issuated CP a sevice complies with other requirements of the Act
that FDA has made a determination that your device complies with other must that I DA has made a determination administered by other Federal agencies. You must of ally Federal Statutes and regulations and including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice Incuration as set forth in the quality systems (OS) regulation (21 CFR Part 820). This letter requirents as as set forth in the quality of wice as described in your Section 510(k) premarket wilf anow you to oogin finding of substantial equivalence of your device to a legally marketed nothleation. The FDT imanig of baseian for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and II you desire specific acritor for your con Diagnostic Device Evaluation and Safety at (301) 796-007), produce venuev are the regulation entitled, "Misbranding by reference to premarket 5456. Thise, promotions and 107.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to under the MDA regulation (21 CFFF at 003), promo goblem/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 Tour may other other general encreational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known):
Device Name: DX-D Imaging Package
Indications for Use:
Agfa's DX-D Imaging Package is indicated for use in general projection radiographic applications to capture for display diagnostic quality radiographic images of human anatomy. The DX-D Imaging Package may be used wherever conventional screen-film systems may be used.
Agfa's DX-D Imaging Package is not indicated for use in mammography.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Michael D'Amico
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K121095
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