(33 days)
Not Found
Not Found
No
The provided text does not contain any mention of AI, ML, deep learning, or related terms, nor does it describe functionalities typically associated with AI/ML in medical imaging (like automated detection, segmentation, or analysis beyond standard image processing).
No
The device is indicated for performing diagnostic imaging procedures (radiography, fluoroscopy, angiography) for various anatomical sites and applications, which are diagnostic in nature, not therapeutic.
Yes
Explanation: The device is indicated for performing general radiography, fluoroscopy, and angiography procedures, which are used to acquire images for diagnostic purposes across various anatomical sites and applications (e.g., gastroenterology, skeleton, thorax and lungs). The output of these procedures (images) is used by medical professionals to diagnose conditions.
No
The intended use describes a device for performing radiography, fluoroscopy, and angiography procedures, which are hardware-based imaging modalities. The device name "Discovery RF180" also suggests a physical system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for performing general radiography, fluoroscopy, and angiography procedures. These are imaging techniques used to visualize internal structures of the body.
- Applications and Techniques: The listed applications and techniques (Gastroenterology, Skeleton, Thorax and lungs, etc.) are all related to medical imaging and diagnosis based on visual information from the body.
- Input Imaging Modality: The input modality is X-ray, which is a form of radiation used for medical imaging, not for analyzing samples outside the body.
- Anatomical Site: The anatomical sites mentioned are parts of the human body that are being imaged.
IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. This device does not perform such analysis on specimens. It is a medical imaging device.
N/A
Intended Use / Indications for Use
The CLISIS SYSTEMS, Discovery RF180 is indicated for performing general radiography, fluoroscopy and angiography procedures.
Applications and techniques:
- Gastroenterology -
- -Skeleton
- Thorax and lungs -
- Paediatrics -
- Urology and gynecology -
- Emergency/traumatology -
- Digital angiography
- Linear tomography
- Auto Image Paste (Stitching)
- Tomosynthesis
Product codes
IZF, JAA, MQB, IZI, KXJ
Device Description
Not Found
Mentions image processing
Auto Image Paste (Stitching)
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
- Skeleton
- Thorax and lungs
Indicated Patient Age Range
Paediatrics
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1740 Tomographic x-ray system.
(a)
Identification. A tomographic x-ray system is an x-ray device intended to be used to produce radiologic images of a specific cross-sectional plane of the body by blurring or eliminating detail from other planes. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
October 26, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym and name on the right. The FDA acronym is in a blue square, and the full name "U.S. Food & Drug Administration" is in blue text.
General Medical Merate S.P.A % Marisa Testa CEO & QA/RA Consultant Thema S.R.L. Via Saragat 5 Imola, BO 40026 ITALY
Re: K213081
Trade/Device Name: CLISIS SYSTEMS, Discovery RF180 Regulation Number: 21 CFR 892.1740 Regulation Name: Tomographic x-ray system Regulatory Class: Class II Product Code: IZF, JAA, MQB, IZI, KXJ Dated: September 21, 2021 Received: September 23, 2021
Dear Marisa Testa:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
, for
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213081
Device Name CLISIS SYSTEMS, Discovery RF180
Indications for Use (Describe)
The CLISIS SYSTEMS, Discovery RF180 is indicated for performing general radiography, fluoroscopy and angiography procedures.
Applications and techniques:
- Gastroenterology -
- -Skeleton
- Thorax and lungs -
- Paediatrics -
- Urology and gynecology -
- Emergency/traumatology -
- Digital angiography
- Linear tomography
- Auto Image Paste (Stitching)
- Tomosynthesis
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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