(19 days)
Not Found
No
The document describes image processing software (Musica and Musica2) but does not mention AI, ML, or related terms like deep learning or neural networks. The focus is on hardware improvements and standard image processing techniques.
No
The device is used to create diagnostic quality images for diagnosis, not for treating a disease or condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the systems "are indicated for use in providing diagnostic quality images to aid the physician with diagnosis." This directly indicates that the device is intended for diagnostic purposes.
No
The device description explicitly states it is a "computed radiography imaging system" that captures radiographic exposures on "phosphor plates" and scans them with a "laser" to create an electronic image. These are hardware components, not solely software. While it includes image processing software (Musica/Musica 2), the core device is a hardware system.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide diagnostic quality images to aid physicians in diagnosis. This involves capturing and processing radiographic images of the human body.
- Device Description: The device is a computed radiography imaging system that captures radiographic exposures on phosphor plates and converts them into electronic images.
- Lack of In Vitro Activity: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis. This device works by capturing images of the body in vivo (within the body) using x-rays.
The device is clearly an in vivo diagnostic imaging system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Agfa's Computed Radiography Systems with DX-G Digitizers are indicated for use in providing diagnostic quality images to aid the physician with diagnossis.
Systems can be used with either Musica or Musica 2 image processing to create radiographic images of the skeleton (including skull, spinal column and extremities) chest, abdomen and other body parts.
System options and accessories are available for:
- Pediatric imaging
- Full leg/full spine
- Radiotherapy planning and QC
- Musica2 Platinum (thorax, abdomen or musculoskeletal regions of adult or pediatric patients)
- Musica2 Neonatal
Agfa's Computed Radiography Systems with NX Workstations are not indicated for use in mammography.
Product codes (comma separated list FDA assigned to the subject device)
MQB
Device Description
The new devices are computed radiography imaging systems of similar design and construction to the predicates. The devices capture radiographic exposures on phosphor plates that are then scanned with a laser to create an electronic image. Electronic images can then be manipulated, printed, or sent to a softcopy capable display or archive such as a PACS system.
New DX-G digitizers provide the following new benefits:
- The ability to use both standard and needle phosphor image plates with a single digitizer.
- Input and output cassette storage buffers that allow the x-ray technologist to load up to five exposed cassettes at a time. The cassettes can be of any type and size, freeing the technologist from having to process and wait on each image separately.
- An image data format that provides slightly improved latitude for over-exposures.
The principles of operation of the new and predicate devices are the same. They have the same underlying technological characteristics.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-rays
Anatomical Site
skeleton (including skull, spinal column and extremities) chest, abdomen and other body parts.
Indicated Patient Age Range
Adult or pediatric patients, Neonatal
Intended User / Care Setting
Physician, X-ray technologist
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Agfa's Computed Radiography (CR) Systems with DX-G Digitizers have been tested for proper performance to specifications through various internal tests. Components have been tested and shown to meet the requirements of EN 60601-1-1 and EN 60601-1-2.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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).
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§ 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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510(K) SUMMARY AGFA COMPUTED RADIOGRAPHY (CR) SYSTEMS WITH DX-G DIGITIZERS
Common/Classification Name: Computed Radiography System, 21 CFR 892.1650 Proprietary Name: Computed Radiography (CR) Systems With DX-G Digitizers Agfa HealthCare N.V. Septestraat 27 B-2640 Mortsel AUG 1 1 2009 Belgium Contact: Jeffery A. Jedlicka, Prepared: July 13, 2009 Telephone: (864) 421-1815 Facsimile: (864) 421-1635
A. LEGALLY MARKETED PREDICATE DEVICES
This is a 510(k) for Agfa's Computed Radiography Systems with DX-G Digitizers. The predicate devices are Agfa's Computed Radiography Systems with NX Workstations (K090672).
B. DEVICE DESCRIPTION
The new devices are computed radiography imaging systems of similar design and construction to the predicates. The devices capture radiographic exposures on phosphor plates that are then scanned with a laser to create an electronic image. Electronic images can then be manipulated, printed, or sent to a softcopy capable display or archive such as a PACS system.
New DX-G digitizers provide the following new benefits:
- The ability to use both standard and needle phosphor image plates with a single digitizer.
- 0 Input and output cassette storage buffers that allow the x-ray technologist to load up to five exposed cassettes at a time. The cassettes can be of any type and size, freeing the technologist from having to process and wait on each image separately.
- . An image data format that provides slightly improved latitude for over-exposures.
The principles of operation of the new and predicate devices are the same. They have the same underlying technological characteristics.
C. INTENDED USE
Agfa's Computed Radiography Systems with DX-G Digitizers have the same intended use as the predicate devices:
They are intended for use in providing diagnostic quality images to aid the physician with diagnosis.
Systems can be used with either Musica or Musica2 image processing to create radiographic images of the skeleton (including skull, spinal column and extremities) chest, abdomen and other body parts.
System options and accessories are available for:
- Pediatric imaging .
- Full leg/full spine ●
- . Radiotherapy planning and QC
- Musica2 Platinum (thorax, abdomen or musculoskeletal regions of adult or pediatric . patients)
- Musica2 Neonatal .
In the USA, Agfa's Computed Radiography Systems with DX-G Digitizers are not intended for use in mammography.
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SUBSTANTIAL EQUIVALENCE SUMMARY D.
Agfa's Computed Radiography (CR) Systems with DX-G Digitizers have the same indications for use statement as the legally marketed predicate devices (those with NX software). 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.
TECHNOLOGICAL CHARACTERISTICS E.
The technological characteristics are the same in the proposed and predicate devices. Both the predicate and new devices use x-rays received by photostimulable plates to create latent diagnostic images. Plates are then scanned by a laser which converts the images into a digital form that can be previewed, adjusted if necessary, then stored locally, sent to an archive, printed or sent to a softcopy capable display such as a PACS system.
TESTING F.
Agfa's Computed Radiography (CR) Systems with DX-G Digitizers have been tested for proper performance to specifications through various internal tests. Components have been tested and shown to meet the requirements of EN 60601-1-1 and EN 60601-1-2.
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 seal on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The seal features an image of a caduceus, a symbol of medicine, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter.
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
AUG 2 3 2013
Re: K092238
Trade/Device Name: Computed Radiography (CR) Systems with DX-G Digitizers Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: July 22, 2009 Received: July 23, 2009
Dear Mr. Job:
This letter corrects our substantially equivalent letter of August 11, 2009.
We have reviewed vour 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
092239 510(k) Number (if known):
Device Name: Computed Radiography (CR) Systems with DX-G Digitizers
Indications for Use:
Agfa's Computed Radiography Systems with DX-G Digitizers are indicated for use in providing diagnostic quality images to aid the physician with diagnossis.
Systems can be used with either Musica or Musica 2 image processing to create radiographic images of the skeleton (including skull, spinal column and extremities) chest, abdomen and other body parts.
System options and accessories are available for:
- Pediatric imaging ●
- Full leg/full spine .
- Radiotherapy planning and QC .
- Musica2 Platinum (thorax, abdomen or musculoskeletal regions of adult or ● pediatric patients)
- Musica2 Neonatal .
Agfa's Computed Radiography Systems with NX Workstations are not indicated for use in mammography.
| Prescription Use X | AND/OR | Over-The-Counter Use ______ |
|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE OF NEEDED)
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K092238 |
Concurrence of CDRH, Office of Device Evaluation (ODE)