(67 days)
Not Found
No
The document mentions "MUSICA2 image processing" but does not contain any terms or descriptions indicative of AI or ML technology.
No
The device is indicated for providing diagnostic quality images, not for treating conditions or diseases.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for use in providing diagnostic quality images to aid the physician with diagnosis."
No
The device description explicitly mentions hardware components like flat panel detectors and an NX workstation, indicating it is a hardware and software system, not software-only.
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 Agfa's DX-D Imaging Package is an imaging system that uses X-rays to create radiographic images of the internal structures of the body. It does not analyze samples taken from the body.
- Intended Use: The intended use is to provide diagnostic quality images to aid physicians in diagnosis, which is a function of medical imaging devices, not IVDs.
The device is a medical imaging device used for diagnostic purposes, but it operates by capturing images of the body directly, not by analyzing samples in vitro.
N/A
Intended Use / Indications for Use
Agfa's DX-D Imaging Package is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2TM image processing to create radiographic images of the skeleton (including skull, spinal column and extremities) chest, abdomen and other body parts. Agfa's DX-D Imaging Package is not indicated for use in mammography.
Product codes (comma separated list FDA assigned to the subject device)
MOB
Device Description
The new device is a direct radiography imaging system of similar design and construction to the predicates. Agfa's DX-D Imaging Package uses Agfa's familiar NX workstation with MUSICA2TM image processing and flat panel detectors of the scintillator-photodetector type. Flat panel detectors with scintillators of both Cesium Iodide (Csl) and Gadolinium Oxysulfide (GOS) are available. The device is used to capture and digitize x-ray images without a separate digitizer common to computed radiography systems. Principles of operation and technological characteristics of the new and predicate devices are the same.
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 other body parts.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / 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)
The new device combines proven technology from both predicates. It combines the NX user workstation of the Agfa predicate with flat panel detectors of the Varian predicate. Differences between the new device and the predicates are minor and have been evaluated via laboratory testing and in an image comparison study.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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NOV - 6 2009
510(K) SUMMARY: AGFA DX-D IMAGING PACKAGE
Common/Classification Name: Computed Radiography System, 21 CFR 892.1650 Proprietary Name: DX-D Imaging Package Agfa HealthCare N.V. Septestraat 27 B-2640 Mortsel Belgium Contact: Jeffery A. Jedlicka, Prepared: August 18 2009 Telephone: (864) 421-1815 Facsimile: (864) 421-1635
A. LEGALLY MARKETED PREDICATE DEVICES
This is a 510(k) for Agfa's DX-D Imaging Package. The predicate devices are two devices with similar technology: Agfa's Computed Radiography Systems with NX Workstations (K090672) and Varian Medical's PaxScan 4030 (K024147).
B. DEVICE DESCRIPTION
The new device is a direct radiography imaging system of similar design and construction to the predicates. Agfa's DX-D Imaging Package uses Agfa's familiar NX workstation with MUSICA2TM image processing and flat panel detectors of the scintillator-photodetector type. Flat panel detectors with scintillators of both Cesium Iodide (Csl) and Gadolinium Oxysulfide (GOS) are available. The device is used to capture and digitize x-ray images without a separate digitizer common to computed radiography systems.
Principles of operation and technological characteristics of the new and predicate devices are the same.
C. INTENDED USE
Agfa's DX-D Imaging Package has the same intended use as the predicate devices; namely to provide diagnostic images to assist the physician with diagnosis.
The device uses Agfa's flat panel detectors with amorphous silicon scintillators and NX workstations with MUSICA image processing to create radiographic images of the skeleton (including skull, spinal column and extremities) chest, abdomen and other body parts.
Agfa's DX-D Imaging Package is not indicated for use in mammography.
D. SUBSTANTIAL EQUIVALENCE SUMMARY '
Agfa's DX-D Imaging Package has a similar Indications For Use statement as the legally marketed predicate device (Agfa DX-S with NX workstation). The devices have the same technological characteristics. Descriptive characteristics and performance data are adequate to ensure equivalence.
Differences in devices do not alter the intended therapeutic/diagnostic effect.
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E. TECHNOLOGICAL CHARACTERISTICS
Agfa's DX-D Imaging Package is substantially equivalent to a prior Agfa computed radiography systems (K090672) and to a similar Varian direct radiography system (K024147). The new device has an indications statement largely similar to that of the Agfa predicate. Intended uses of all the devices are the same, namely to provide diagnostic quality images.
F. TESTING
The new device combines proven technology from both predicates. It combines the NX user workstation of the Agfa predicate with flat panel detectors of the Varian predicate. Differences between the new device and the predicates are minor and have been evaluated via laboratory testing and in an image comparison study.
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/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo includes the department's emblem on the left, which features a stylized human figure. To the right of the emblem, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is displayed in a clear, sans-serif font.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
AGFA Healthcare Corporation % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services. LLC 1394 25th Street NW BUFFALO MN 55313
Re: K092669
Trade/Device Name: DX-D Imaging Package Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: October 5, 2009 Received: October 29, 2009
AUG 2 3 2013
Dear Mr. Job:
This letter corrects our substantially equivalent letter of November 6, 2009.
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 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 requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/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
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Indications for Use
510(k) Number (if known): K1922669
Device Name: DX-D Imaging Package
Indications for Use:
Agfa's DX-D Imaging Package is indicated for use in providing diagnostic quality images to aid the physician with diagnosis.
Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton (including skull, spinal column and extremities) chest, abdomen and other body parts.
Agfa's DX-D Imaging Package is not indicated for use in mammography.
AND/OR
Prescription Use X (Part 21 CFR 801 Subpart D) 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 Device Evaluation (ODE)
Herbstmann
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devi 510(k) Number