(17 days)
Not Found
No
The document describes standard computed radiography technology and image processing techniques (MUSICA, MUSICA2) without mentioning AI or ML. The performance studies focus on image quality comparison to a predicate device, not on AI/ML model performance metrics.
No
The device is an imaging system used for diagnostic purposes, not for treating diseases or conditions.
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 clearly indicates its role in providing images for diagnosis.
No
The device description explicitly states it is a "solid state x-ray imaging device" and includes hardware components like a "Laser digitizer" and "Phosphor coated imaging plates and cassettes". While it includes software (NX workstation), it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "general projection radiographic applications to capture for display diagnostic quality radiographic images of human anatomy." This involves imaging the internal structures of the body using X-rays.
- Device Description: The description details a system that captures and processes X-ray images using imaging plates, a digitizer, and a workstation. This is consistent with medical imaging equipment used for diagnostic purposes in vivo (within the living body).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the living body) to provide information about a physiological state, health, or disease.
IVD devices are specifically designed to perform tests on samples taken from the body. This device is designed to capture images of the body itself.
N/A
Intended Use / Indications for Use
Agfa's Computed Radiography (CR) System with CR 10-X Digitizer is indicated for use in general projection radiographic applications to capture for display diagnostic quality radiographic images of human anatomy. The system may be used wherever conventional screen-film systems are used.
Agfa's Computed Radiography (CR) System With CR 10-X Digitizer is not indicated for use in mammography.
Product codes (comma separated list FDA assigned to the subject device)
MQB
Device Description
Agfa's Computed Radiography (CR) Systems with CR 10-X Digitizer is a solid state x-ray imaging device. Principles of operation and technological characteristics of the new and predicate devices are largely the same as other computed radiography systems:
- Phosphor coated imaging plates and cassettes for image capture.
- Laser digitizer for generating the electronic image. .
- NX workstation for image previewing, processing and routing.
Agfa's Computed Radiography (CR) Systems with CR 10-X Digitizer is a solid state x-ray imaging device. It uses phosphor coated imaging plates to capture an x-ray exposure. Upon scanning of the image plates by the CR-10-X digitizer, the x-ray image is read and transmitted to the NX workstation where the image can be previewed, processed and transmitted to other devices for viewing, printing or storage.
Mentions image processing
Yes
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
The device has completed verification and validation testing to confirm it meets specifications and operates as planned. Tests included image quality tests with internal and experts comparing the device to its predicate.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Tests included image quality tests with internal and experts comparing the device to its predicate. The product, manufacturing and development processes have been shown to conform to product safety, radiology, and imaging standards including: IEC 60601-1, IEC 60601-1-2, ACR/NEMA PS3.1-3.18, ISO 14971, ISO 13485.
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.
0
JUL 20 2012
Agfa HealthCare NV Premarket Notification: Computed Radiography (CR) Systems with CR 10-X Digitizer
510(K) SUMMARY
Agfa Computed Radiography (CR) Systems with CR 10-X Digitizer
Common Name: Computed Radiography System Classification Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Classification: 21 CFR 892.1650 Product Code: MQB Proprietary Name: Computed Radiography (CR) Systems with CR 10-X Digitizer Agfa HealthCare N.V. Septestraat 27 B-2640 Mortsel Belgium Contact: Phil Cuscuna, Prepared: April 10, 2012 Telephone: (416) 240-7317 Facsimile: (416) 240-7359
A. LEGALLY MARKETED PREDICATE DEVICES
This is a 510(k) for Agfa's Computed Radiography (CR) System with CR 10-X Digitizer, a solid state x-ray imaging device. It is substantially equivalent to systems with Agfa's CR 30-X digitizer (K062223).
B. DEVICE DESCRIPTION
Agfa's Computed Radiography (CR) Systems with CR 10-X Digitizer is a solid state x-ray imaging device. Principles of operation and technological characteristics of the new and predicate devices are largely the same as other computed radiography systems:
- Phosphor coated imaging plates and cassettes for image capture.
- Laser digitizer for generating the electronic image. .
- NX workstation for image previewing, processing and routing .
C. INTENDED USE
Agfa's Computed Radiography (CR) System with CR 10-X Digitizer is indicated for use in general projection radiographic applications to capture for display diagnostic quality radiographic images of human anatomy. The system may be used wherever conventional screen-film systems are used.
Agfa's Computed Radiography (CR) System With CR 10-X Digitizer is not indicated for use in mammography.
1
Agfa HealthCare NV Premarket Notification: Computed Radiography (CR) Systems with CR 10-X Digitizer
SUBSTANTIAL EQUIVALENCE SUMMARY D.
Agfa"s Computed Radiography (CR) System with CR 10-X Digitizer has an Indications For Use statement similar to the statement for the predicate device, K062223. Intended uses are the same. 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.
| PRODUCT COMPARISON TABLE | ||
|---|---|---|
| Systems with CR 10-X Digitizer | ||
| (New Device) | Systems with CR 30-X Digitizer | |
| (PREDICATE-K062223) | ||
| Communications | Same as predicate | DICOM |
| Cassette and Image Plates | ||
| Cassettes and Image | ||
| Plate Sizes | 35x43 cm | 15x30 cm |
| 18x24 cm | ||
| 24x30 cm | ||
| 35x35 cm | ||
| 35x43 cm | ||
| Image Plate Phosphors | Same as predicate | BaSrFBrI:Eu |
| Digitizer | ||
| Scanning technology | Same as predicate | Point at-a-time |
| Light collection | Same as predicate | Solid, high efficiency |
| Scanning resolution | Same as predicate | 100μ |
| Active matrix | 3420 x 4218 | 3480 x 4248 |
| Dynamic range | ||
| (acquisition) | Same as predicate | 16 bit, sq. root compressed |
| Throughput | ||
| (35x43 cm plates/hr.) | 34 | 60 |
| Power Supply | Same as predicate | 100 - 240V 50/60 Hz |
| Mobile installations | Same as predicate | Mobile mounting option |
| Image stitching | Same as predicate | Full Leg Full Spine |
| Workstation | ||
| Image processing | Same as predicate | MUSICA, MUSICA2 |
| Dynamic range | ||
| (display) | Same as predicate | 12 bit |
| Operating system | Windows 7 | Windows XP Pro |
| Power Supply | Same as predicate | 100 - 240V 50/60 Hz |
| Display System | Same as predicate | Standard PC display or separately cleared |
| medical display |
2
E. TECHNOLOGICAL CHARACTERISTICS
Agfa's Computed Radiography (CR) Systems with CR 10-X Digitizer is a solid state x-ray imaging device. It uses phosphor coated imaging plates to capture an x-ray exposure. Upon scanning of the image plates by the CR-10-X digitizer, the x-ray image is read and transmitted to the NX workstation where the image can be previewed, processed and transmitted to other devices for viewing, printing or storage.
F. TESTING
The device has completed verification and validation testing to confirm it meets specifications and operates as planned. Tests included image quality tests with internal and experts comparing the device to its predicate.
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
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.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus symbol.
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
JUL 20 2012
Agfa Healthcare N.V. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K121948
Trade/Device Name: CR 10-X Digitizer Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: MQB Dated: July 2, 2012 Received: July 3, 2012
Dear Mr. Job:
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 ror association 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 or uny 1 vith 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
4
medical device-related adverse events) (21 CFR 803); and good manufacturing practice mourements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirenchs as set forth in the quality of over as described in your Section 510(k) premarket whil anow you to ocgainmarketing your substantial equivalence of your device to a legally marketed nonication. The I Drice 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 11 you desire specific davice of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket 5456. Thise, productions are regarding the 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 Tou may other other geficiturers, 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
5
Indications for Use Form
510(k) Number (if known):
Device Name: CR 10-X Digitizer
Indications for Use:
Agfa's Computed Radiography (CR) System with CR 10-X Digitizer is indicated for use in general projection radiographic applications to capture for display diagnostic quality radiographic images of human anatomy. The system may be used wherever conventional screen-film systems are used.
Agfa's Computed Radiography (CR) System With CR 10-X Digitizer 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)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
21(
Page 1 of