(15 days)
Not Found
No
The document describes standard computed radiography systems with image processing software (Musica, Musica2, Musica2 Platinum). There is no mention of AI, ML, deep learning, training data, test data, or performance metrics typically associated with AI/ML devices. The focus is on hardware and software updates for image acquisition and processing, not intelligent analysis or interpretation.
No
The device is indicated for providing diagnostic quality images, not for treating conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is "indicated for use in providing diagnostic quality images to aid the physician with diagnosis."
No
The device description explicitly states "updated hardware and software" and mentions components being tested to meet EN 60601-1-1 and EN 60601-1-2, which are standards for medical electrical equipment, indicating the presence of hardware.
Based on the provided text, 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 this device is a Computed Radiography System. It uses X-rays and photostimulable plates to create radiographic images of the internal structures of the body. This is an in vivo imaging technique, meaning it is performed on a living organism.
- Intended Use: The intended use is to provide diagnostic quality images to aid the physician with diagnosis based on these radiographic images. This is consistent with medical imaging, not in vitro testing.
Therefore, the function and intended use of this device fall under the category of medical imaging systems, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Agfa's Computed Radiography Systems with NX 2008 software are indicated for use in providing diagnostic quality images to aid the physiclan with diagnosis.
The systems can be used with either Musica, Musica2 or Musica2 Platinum image processing to create radiographic images of the skeleton (including skull, spinal column and extremities) chest, abdomen and other body parts.
When used with separately cleared accessories the systems can be conveniently used to generate urological, tomographic, pediatric and dental images, and for radiotherapy planning and quality control.
When used with Musica2 Platinum software the systems are indicated for creating high quality images of the thorax, abdomen or musculoskeletal regions of adult or pediatric patients.
Agfa's Computed Radiography Systems with NX 2008 software are not indicated for use in mammography.
Product codes
MOB
Device Description
The predicate and new devices are nearly identical computed radiography imaging systems. NX 2008 systems (new devices) have updated hardware and software that offers:
- An optional medical grade display. The display is cleared separately . by the display manufacturer.
- The capability to operate as a mixed-use system for both general . radiography and mammography (where approved or licensed). This is not the case for the USA the separately licensed mammography system is not available.
- Improved tools for installation, configuration and management. .
- The ability to receive DICOM veterinary images and data. .
The basic 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-ray
Anatomical Site
skeleton (including skull, spinal column and extremities) chest, abdomen and other body parts; urological, tomographic, pediatric and dental images, and for radiotherapy planning and quality control; thorax, abdomen or musculoskeletal regions
Indicated Patient Age Range
adult or pediatric patients
Intended User / Care Setting
physician
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)
Agfa's Computed Radiography (CR) Systems with NX2008 Workstations 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. No clinical testing was involved
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Controlled 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.
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Agfa Corporation Agra Corporation
Premarket Notification: Computed Radiography Systems With NX 2008 Workstations JUL 2 5 2008
510(k) Summary DX-Si
Common/Classification Name: Computed Radiography, 21 CFR 892.1650 Proprietary Name: Computed Radiography (CR) Systems with NX 2008 Workstations
Agfa HealthCare Corporation 10 South Academy Street Greenville. SC 29602-9048
Contact: Jeffery A. Jedlicka, Prepared: May 6, 2008 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 NX 2008 Workstations. The predicate devices are Agfa's Computed Radiography Systems with NX2.0 Workstations (K071162).
DEVICE DESCRIPTION B.
The predicate and new devices are nearly identical computed radiography imaging systems. NX 2008 systems (new devices) have updated hardware and software that offers:
- An optional medical grade display. The display is cleared separately . by the display manufacturer.
- The capability to operate as a mixed-use system for both general . radiography and mammography (where approved or licensed). This is not the case for the USA the separately licensed mammography system is not available.
- Improved tools for installation, configuration and management. .
- The ability to receive DICOM veterinary images and data. .
The basic principles of operation of the new and predicate devices are the same. They have the same underlying technological characteristics.
INTENDED USE C.
Agfa's Computed Radiography Systems with NX 2008 software are indicated for use in providing diagnostic quality images to aid the physician with diagnosis.
The systems can be used with either Musica, Musica2 or Musica2 Platinum image processing to create radiographic images of the skeleton (including skull, spinal column and extremities) chest, abdomen and other body parts.
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When used with separately cleared accessories the systems can be conveniently used to generate urological, tomographic, pediatric and dental images, and for radiotherapy planning and quality control.
When used with Musica2 Platinum software the systems are indicated for creating high quality images of the thorax, abdomen or musculoskeletal regions of adult or pediatric patients.
Agfa's Computed Radiography Systems with NX 2008 software are not indicated for use in mammography.
SUBSTANTIAL EQUIVALENCE SUMMARY D.
These Computed Radiography (CR) Systems With NX 2008 Workstations have the same indications for use statement as the legally marketed predicate devices (those with NX2.0 software).
The intended uses of the new and predicate devices are highly similar.
- . Users of the new device have the ability to purchase the device with a separately cleared medical grade display instead of reading images only on other (external) medical displays, or on films.
- The system can operate in a mixed-use mode for general radiography . and mammography (not in the USA).
- . The ability to receive and transmit DICOM veterinary images.
- The user interface and system documentation are available in a . number of additional languages.
- Installation, configuration and management of the system is simplified .
Digitizers and cassettes are unchanged from the predicates.
The differences do not alter the intended therapeutic/diagnostic effect.
TECHNOLOGICAL CHARACTERISTICS ui
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 diode array 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.
F. TESTING
Agfa's Computed Radiography (CR) Systems with NX2008 Workstations 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. No clinical testing was involved
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G. CONCLUSIONS
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/1 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 that resembles a stylized human figure or a bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Agfa HealthCare Corporation % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
MAY - 7 2012
Re: K081963
Trade/Device Name: Computed Radiography (CR) Systems with NX 2008 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: MOB Dated: July 9, 2008 Received: July 10, 2008
Dear Mr. Job:
This letter corrects our substantially equivalent letter of July 25, 2008.
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. Iisting 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 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):
Device Name: Computed Radiography (CR) Systems with NX 2008
Indications for Use:
Agfa's Computed Radiography Systems with NX 2008 software are indicated for use in providing diagnostic quality images to aid the physiclan with diagnosis.
The systems can be used with either Musica, Musica2 or Musica2 Platinum image processing to create radiographic images of the skeleton (including skull, spinal column and extremities) chest, abdomen and other body parts.
When used with separately cleared accessories the systems can be conveniently used to generate urological, tomographic, pediatric and dental images, and for radiotherapy planning and quality control.
When used with Musica2 Platinum software the systems are indicated for creating high quality images of the thorax, abdomen or musculoskeletal regions of adult or pediatric patients.
Agfa's Computed Radiography Systems with NX 2008 software are not indicated for use in mammography.
Prescription Use × (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 Device Evaluation (ODE)
Hopal Mwhan
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices K081963 510(k) Number ________________________________________________________________________________________________________________________________________________________________
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