MECALL CLISIS SYSTEMS, Discovery RF180

K173395 · General Medical Merate S.P.A · JAA · May 21, 2018 · Radiology

Device Facts

• Record ID: K173395
• Device Name: MECALL CLISIS SYSTEMS, Discovery RF180
• Applicant: General Medical Merate S.P.A
• Product Code: JAA · Radiology
• Decision Date: May 21, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1650
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The MECALL CLISIS SYSTEMS, Discovery RF180 is indicated for performing general radiography, fluoroscopy and angiography procedures/applications. The device is intended for use in: - Skeleton - Chest and lungs - Pediatrics - Emergency/traumatology - Gastroenterology - Urology and gynecology - Linear tomography - Digital angiography - Stitching

Device Story

MECALL CLISIS SYSTEMS, Discovery RF180 is an image-intensified fluoroscopic X-ray system. Device captures X-ray images for diagnostic visualization in clinical settings (radiology, emergency, surgery). Operated by trained healthcare professionals (radiologists, technicians). System supports general radiography, fluoroscopy, angiography, linear tomography, and stitching. Output is digital radiographic/fluoroscopic imagery used by clinicians to diagnose conditions in skeleton, chest, lungs, gastrointestinal, urological, and gynecological systems. Facilitates clinical decision-making through high-resolution imaging; aids in patient management for trauma and routine diagnostic procedures.

Clinical Evidence

No clinical data provided. Substantial equivalence established via bench testing and comparison of technological characteristics.

Technological Characteristics

Image-intensified fluoroscopic X-ray system. Class II device (21 CFR 892.1650). Product code JAA. Supports digital imaging, linear tomography, and stitching applications.

Indications for Use

Indicated for general radiography, fluoroscopy, and angiography procedures in pediatric and adult populations across skeletal, thoracic, gastrointestinal, urological, and gynecological applications, including emergency/trauma settings.

Regulatory Classification

Identification

An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo.

May 21, 2018

General Medical Merate S.P.A % Ms. Marisa Testa QA/RA Manager Thema S.r.1. Via Saragat 5 Imola, Bo 40026 ITALY

Re: K173395

Trade/Device Name: MECALL CLISIS SYSTEMS, Discovery RF180 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA Dated: April 18, 2018 Received: April 23, 2018

Dear Ms. 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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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## Page 2 - Ms. Marisa Testa

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Hse 2. Nils

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K173395

Device Name

MECALL CLISIS SYSTEMS, Discovery RF180

Indications for Use (Describe)

The MECALL CLISIS SYSTEMS, Discovery RF180 is indicated for performing general radiography, fluoroscopy and angiography procedures/applications.

The device is intended for use in:

- Skeleton
- Chest and lungs
- Pediatrics
- Emergency/traumatology
- Gastroenterology
- Urology and gynecology
- Linear tomography
- Digital angiography
- Stitching

| Type of Use ( <i>Select one or both, as applicable</i> ) |
|----------------------------------------------------------|
|----------------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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