(28 days)
Not Found
No
The summary describes standard digital image processing and enhancement software, which is common in medical imaging devices and does not inherently indicate the use of AI/ML. There is no mention of AI, ML, deep learning, or any related concepts.
No
The device is described as generating radiographic images and replacing film/screen systems for diagnostic procedures, not for treatment or therapy.
Yes
The device is indicated for use in generating radiographic images of human anatomy and is intended to replace radiographic film/screen systems in general-purpose diagnostic procedures. The "Summary of Performance Studies" also mentions "diagnostic capabilities."
No
The device description explicitly states the system consists of a CR Reader, a QC Workstation with software, cassettes, and image plates, indicating it includes significant hardware components beyond just software.
Based on the provided information, the CRystalView R200 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is "generating radiographic images of human anatomy" and "to replace radiographic film/screen systems in all general-purpose diagnostic procedures." This clearly describes an in vivo imaging system, meaning it is used to image the inside of a living organism (in this case, a human).
- Device Description: The description details a system that reads photostimulable phosphor image plates exposed using standard X-ray systems. This is consistent with medical imaging of the body, not testing of samples outside the body.
- Input Imaging Modality: Computed Radiography (CR) is an imaging modality used for capturing images of the body.
- Anatomical Site: "human anatomy" refers to the structure of the human body, which is imaged directly.
In Vitro Diagnostics (IVDs) are devices used to examine specimens derived from the human body (such as blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The CRystalView R200 does not perform any such testing on biological samples.
N/A
Intended Use / Indications for Use
CRystalView R200 is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures.
Product codes
MQB
Device Description
The Alara CRystalView® R200 is a desktop Computed Radiography (CR) system designed to generate digital x-ray images by reading photostimulable phosphor image plates exposed using standard X-ray systems and techniques. The system consists of a CR Reader, a QC Workstation with software, cassettes, and image plates. Image data is sent via a dedicated connection from the Reader to the CRystalView R200 OC Workstation, where it is processed and displayed for review. The system outputs images and patient information to a PACS using the standard DICOM 3.0 protocol. The fully configured CRystalView R200 System includes acquisition console software and postprocessing image enhancement software. A reseller may alternatively provide these two software components or appropriately cleared equivalents, as well as the QC Workstation hardware.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Alara has performed laboratory and clinical studies to demonstrate that CRystalView R200 performance characteristics and diagnostic capabilities are equivalent to the predicates. The results of these studies show that CRystal View R200 performance characteristics are comparable with those of the predicate devices. Clinically, no statistically significant difference was found in image quality ratings of CRystalView R200 and the Agfa ADC Compact when images were judged by a radiologist.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
Image /page/0/Picture/0 description: The image shows the logo for ALARA Incorporated. The logo consists of the letters A, L, A, R, and A, each separated by a vertical line. The word "INCORPORATED" is written in smaller letters below the logo.
Attachment D: 510(k) Summary
JUN 3 0 2006
CRystalView® R200 Computed Radiography System
Kolo 1538
This summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92.
Submitter:
Alara, Inc. 47505 Seabridge Drive Fremont, CA 94538
- Contact Person: Diane King VP Regulatory Affairs Phone: 510-315-5173 510-315-5201 Fax:
Date Prepared: May 30, 2006
Trade Name: CRystalView® R200 Computed Radiography System
Common Name: Computed Radiography (CR) System
Classification Name: Solid State X-Ray Imager (per 21 CFR 892.1650)
| Predicate Devices: | 510(k)# |
|---|---|
| Alara CrystalView CR System | |
| Agfa ADC Compact | K032210 |
| K974597 |
Product Description:
The Alara CRystalView® R200 is a desktop Computed Radiography (CR) system designed to generate digital x-ray images by reading photostimulable phosphor image plates exposed using standard X-ray systems and techniques. The system consists of a CR Reader, a QC Workstation with software, cassettes, and image plates. Image data is sent via a dedicated connection from the Reader to the CRystalView R200 OC Workstation, where it is processed and displayed for review. The system outputs images and patient information to a PACS using the standard DICOM 3.0 protocol. The fully configured CRystalView R200 System includes acquisition console software and postprocessing image enhancement software. A reseller may alternatively provide these two software components or appropriately cleared equivalents, as well as the QC Workstation hardware.
Indications for Use:
CRystalView R200 is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all generalpurpose diagnostic procedures.
1
KOL 153 8
Rationale for Substantial Equivalence:
CRystalView R200 has the same indication for use as the predicate devices. CRystal View R200 shares the same technological characteristics as the predicate devices. However, the descriptive characteristics are not sufficiently precise to assure substantial equivalence. Therefore, Alara has carried out verification and image quality performance testing, including a confirmatory clinical concurrence study. The results of this testing demonstrate that CRystalView R200 is substantially equivalent to the predicate devices.
Safety and Effectiveness Information:
CRystalView R200 is a Class II medical device and a Class I laser product. CRystalView R200 complies with applicable FDA and international standards pertaining to electrical, mechanical, EMC, and laser safety of medical and/or laser devices.
Alara has performed laboratory and clinical studies to demonstrate that CRystalView R200 performance characteristics and diagnostic capabilities are equivalent to the predicates. The results of these studies show that CRystal View R200 performance characteristics are comparable with those of the predicate devices. Clinically, no statistically significant difference was found in image quality ratings of CRystalView R200 and the Agfa ADC Compact when images were judged by a radiologist.
Conclusion:
CRystalView R200 performance tests and clinical studies have demonstrated that CRystalView R200 is substantially equivalent to the predicate devices.
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo includes the department's name in blue, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" written in a clear, sans-serif font. To the left of the text is a symbol featuring a stylized human figure, also in blue, which is part of the department's official emblem.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Diane M. King Vice President, Regulatory Affairs Alara, Inc. 47505 Seabridge Drive FREMONT CA 94538
AUG 2 3 2013
Re: K061538
Trade/Device Name: Alara CRystalView® R200 Computed Radiography System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: June 1, 2006 Received: June 2, 2006
Dear Ms. King:
This letter corrects our substantially equivalent letter of June 30, 2006.
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
3
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
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
4
Attachment B: Indications for Use Statement
510(k) Number: K061538
Device Name:
Alara CRystalView® R200 Computed Radiography System
Indications for Use: CRystalView R200 is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
'rescription Use
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K061538