(276 days)
Not Found
No
The summary describes a standard Computed Radiography (CR) system and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is described as generating radiographic images for diagnostic procedures, not for treating or preventing diseases.
Yes
The device is described as "intended to replace radiographic filmscreen systems in all general-purpose diagnostic procedures," indicating its use in diagnostic imaging.
No
The device description explicitly states that the system consists of hardware components including a CR reader, imaging plates, and cassettes, in addition to 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 "generating radiographic images of human anatomy" and is intended to "replace radiographic filmscreen systems in all general-purpose diagnostic procedures." This describes an imaging system used to visualize internal structures of the body.
- Device Description: The description details a Computed Radiography (CR) system that reads exposed imaging plates to generate digital x-ray images. This is consistent with medical imaging equipment.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health. The provided information does not mention any analysis of biological specimens.
Therefore, the Alara T210 Computed Radiography System is a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Alara T210 Computed Radiography System is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic filmscreen systems in all general-purpose diagnostic procedures. The T210 is not indicated for use in mammography.
Product codes (comma separated list FDA assigned to the subject device)
MOB
Device Description
The Alara T210 is a desktop Computed Radiography (CR) system designed to generate digital x-ray images by reading photostimulable phosphor imaging plates exposed using standard x-ray systems and techniques. The system consists of a CR read or iposeing plates, and cassettes. A computer workstation and OC Acquisition software, will be optionally provided by either Alara or the distribution channel.
Mentions image processing
Not Found
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 studies comparing the T210's performance characteristics to those for the predicate.
Performance testing of the Alara T210 Computed Radiography system has demonstrated that it is substantially equivalent to the predicate device.
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.
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JUN - 2 2011
Attachment D: 510(k) Summary
Alara T210 Computed Radiography System
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: Christopher R. Mitchell Chief Scientific Officer Phone: (510) 315-5172 Fax: (510) 315-5201 Email: cmitchell @alara.com
Date Prepared: August 5, 2010
Trade Name: Alara T210 Computed Radiography System
Common Name: Computed Radiography (CR) System
Classification Name: Solid State X-Ray Imager (per 21 CFR 892.1650)
Predicate Device: CRystalView T-Series Computed Radiography System (510(k) No. K071682, August 15, 2007)
Product Description:
The Alara T210 is a desktop Computed Radiography (CR) system designed to generate digital x-ray images by reading photostimulable phosphor imaging plates exposed using standard x-ray systems and techniques. The system consists of a CR read or iposeing plates, and cassettes. A computer workstation and OC Acquisition software, will be optionally provided by either Alara or the distribution channel.
Indications for Use:
The T210 Computed Radiography System is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film-screens systems in all general-purpose diagnostic procedures. The T210 is not indicated for use in mammography.
Rationale for Substantial Equivalence:
The T210 Computed Radiography System is a modification of the predicate device. It has the same indications for use as the predicate device. It has the same technological characteristics as the predicate device, including using the same optical subassembly. The
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change in image size and system form factor resulted in Alara's decision to conduct substantial equivalence testing through verification and image quality performance testing. The results of this testing demonstrate that the T210 is substantially equivalent to the predicate device.
Safety and Effectiveness Information:
The T210 is a Class II medical device and a Class I laser product. It 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 studies comparing the T210's performance characteristics to those for the predicate.
Conclusion:
Performance testing of the Alara T210 Computed Radiography system has demonstrated that it is substantially equivalent to the predicate device.
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Image /page/2/Picture/0 description: The image shows the logo of the Department of Health & Human Services. The logo consists of an emblem on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The emblem features a stylized depiction of a bird or a wing-like shape in blue. The text is also in blue and is written in a clear, sans-serif font.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Christopher Mitchell Chief Scientific Officer Alara, Inc. 47505 Seabridge Drive FREMONT CA 94538
AUG 2 3 2013
Re: K102479
Trade/Device Name: Alara T210 Computed Radiography System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: March 22, 2011 Received: March 24, 2011
Dear Mr. Mitchell:
This letter corrects our substantially equivalent letter of June 2, 2011.
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 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
Janine M. Morri 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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Attachment B: Indications for Use Statement
510(k) Nümber: _________
Device Name:
Alara T210 Computed Radiography System
Indications for Use: The Alara T210 Computed Radiography System is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic filmscreen systems in all general-purpose diagnostic procedures. The T210 is not indicated for use in mammography.
Macy Slew
(Director Sign Off)
Office of In Vitro
510K K182479