(73 days)
Not Found
No
The document mentions "post-processing image enhancement software" but does not provide any details suggesting the use of AI or ML algorithms for this processing. The description focuses on standard computed radiography technology.
No
The device is used for generating radiographic images for diagnostic purposes, not for providing therapy.
No.
This device generates radiographic images but does not interpret them or provide a diagnosis. Its intended use is to replace film/screen systems for generating images from standard X-ray systems.
No
The device description explicitly states that the system consists of a CR Reader, a QC workstation with hardware, cassettes, and imaging plates, in addition to the software. This indicates it is a system with both hardware and software components, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "generating radiographic images of human anatomy" and "replace radiographic film/screen systems in all general-purpose diagnostic procedures." This describes an imaging system used to visualize internal structures of the body, not a test performed on samples taken from the body (like blood, urine, or tissue).
- Device Description: The description details a system for scanning exposed imaging plates from standard X-ray systems. This is consistent with medical imaging, not in vitro diagnostics.
- Input Imaging Modality: The input is X-ray, which is a form of medical imaging, not a method used in IVD testing.
- Anatomical Site: The device is used on "human anatomy," indicating it interacts with the patient's body directly or indirectly through imaging, not with samples from the body.
IVD devices are specifically designed to perform tests on specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is to create images for diagnostic purposes, which falls under the category of medical imaging devices, not IVDs.
N/A
Intended Use / Indications for Use
CRystalView 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 (comma separated list FDA assigned to the subject device)
90 MQB
Device Description
The Alara CRystalView™ is a Desktop Computed Radiography (CR) System designed to generate digital x-ray images by scanning photo-stimulable storage phosphor imaging plates exposed using standard X-ray systems and techniques. The system consists of a CR Reader, a OC workstation with software, cassettes, and imaging plates. Image data is sent via a dedicated connection from the Reader to the CRystalView QC 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 System includes acquisition console software and post-processing 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 CRystalView performance characteristics and equivalent diagnostic capabilities as the predicate. The results of these studies show that CRystal View performance characteristics are comparable with those of the predicate devices. Clinically, no statistically significant difference was found in image quality ratings of CRystalView and the Agfa ADC Compact when images were judged by a radiologist.
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
032210
Premarket Notification, 510(k) for the CRystalView CR System
Image /page/0/Picture/2 description: The image shows the logo for ALARA Incorporated. The logo consists of the word "ALARA" in large, bold, sans-serif font, with vertical lines separating each letter. Below the word "ALARA" is the word "INCORPORATED" in a smaller, sans-serif font. There is a thick black line above the word "ALARA".
510(k) Summary F.
CrystalView™ Computed Radiography System
OCT = 2 2003
This summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92.
| Submitter: | Alara, Inc.
2545 Barrington Court
Hayward, CA 94545 | | |
|----------------------|------------------------------------------------------------------------------------|----------|--------------------|
| Contact Person: | Diane M. King
VP Regulatory Affairs
Phone: 510-265-6224
Fax: 510-723-0111 | | |
| Date Prepared: | July 18, 2003 | | |
| Trade Name: | CRystalView Computed Radiography System | | |
| Common Name: | Computed Radiography (CR) System | | |
| Classification Name: | Solid State X-Ray Imager (per 21 CFR 892.1650) | | |
| Predicate Device: | PhorMax Eagle Scanner
Agfa ADC Compact | 510(k) # | K001499
K974597 |
Product Description:
The Alara CRystalView™ is a Desktop Computed Radiography (CR) System designed to generate digital x-ray images by scanning photo-stimulable storage phosphor imaging plates exposed using standard X-ray systems and techniques. The system consists of a CR Reader, a OC workstation with software, cassettes, and imaging plates. Image data is sent via a dedicated connection from the Reader to the CRystalView QC 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 System includes acquisition console software and post-processing 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 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.
1
Rationale for Substantial Equivalence
CRystalView has the same or similar indications for use as the predicate devices. CRystalView 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 validation and image quality performance testing, including a clinical concurrence study. The results of this testing demonstrate that CRystalView is substantially equivalent to the predicate devices.
Safety and Effectiveness Information:
CRystalView is a Class II medical device, and a Class I laser product. CRystalView 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 CRystalView performance characteristics and equivalent diagnostic capabilities as the predicate. The results of these studies show that CRystal View performance characteristics are comparable with those of the predicate devices. Clinically, no statistically significant difference was found in image quality ratings of CRystalView and the Agfa ADC Compact when images were judged by a radiologist.
Conclusion:
CRystalView performance tests and clinical studies have demonstrated that CRystalView is substantially equivalent to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle with three lines forming its body and wings. The eagle is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is written around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 2 2003
Ms. Diane M. King VP, Regulatory Affairs Alara, Inc. 2545 Barrington Court HAYWARD CA 64545 Re: K032210
Trade/Device Name: Alara CRystalView™ Computed Radiograph System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified Fluoroscopic x-ray system Regulatory Class: II Product Code: 90 MQB Dated: July 18, 2003 Received: July 21, 2003
Dear Ms. King:
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 either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
3
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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Premarket Notification, 510(k) for the CRystalView CR System
Statement of Indications for Use E.
| 510(k) Number (if known): | K032210 |
|---|---|
| Device Name: | Alara CRystalView TM Computed Radiography System |
| Indications for Use: | CRystalView 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)
Prescription Use
・・
Daniel R. Symons
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number .
(Optional Format 3-10-98)