SEDECAL DIGITAL RADIOGRAPHIC UPGRADE MODEL SDRU-T

K130883 · Sedecal., Sa. · MQB · Apr 18, 2013 · Radiology

Device Facts

• Record ID: K130883
• Device Name: SEDECAL DIGITAL RADIOGRAPHIC UPGRADE MODEL SDRU-T
• Applicant: Sedecal., Sa.
• Product Code: MQB · Radiology
• Decision Date: Apr 18, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

Sedecal Digital Radiographic Upgrade Model SDRU-T is intended for digital image capture use in general radiographic examinations, wherever conventional screenfilm systems may be used, excluding fluoroscopy, angiography and mammography. The kit allows imaging of the skull, chest, shoulders, spine. abdomen, pelvis. and extremities.

Device Story

Digital radiographic upgrade kit for existing X-ray rooms using cassette-based film or CR systems; enables digital image acquisition, processing, and archival. Operates via Digital Radiography Operator Console (DROC) software; allows patient registration, procedure selection, technique adjustment, image preview/QC, and image stitching. Used in clinical settings by radiology staff; images transferred to hardcopy, softcopy, or network archives. Benefits include transition from analog/CR to digital workflow, improved image management, and diagnostic efficiency.

Clinical Evidence

No clinical data required. Bench testing performed including electrical safety, electromagnetic compatibility, and software validation. Test images acquired and evaluated per FDA guidance for solid-state X-ray imaging devices; images verified to be of good diagnostic quality.

Technological Characteristics

Stationary X-ray system upgrade kit. Components: Digital X-ray panels and DROC software. Energy source: X-ray. Connectivity: Networked for image transfer to hardcopy/softcopy/archive. Standards: IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC).

Indications for Use

Indicated for patients requiring general radiographic examinations of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities. Excludes fluoroscopy, angiography, and mammography.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Meridian Medical Universal Digital Interface UDI 1717 (K112527)
• Meridian Medical Universal Digital Interface Wireless - UDI 1417W (K111305)
• Medicatech Krystalrad 660 (K112132)

Submission Summary (Full Text)

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## Sedecal 510(k) Summary 510(k) Number K130883

l. Submitter: SEDECAL SA C/ Pelaya. 9-13. Pol. Ind. Río de Janeiro 28110 Algete. Madrid, España (Spain) Tel.- [phone]. Fax.- [phone] Date Prepared: April 5. 2013 Contact: Mª Luisa Gómez de Agüero. Quality and Regulatory Manager

- 2. Identification of the Device: Proprietary-Trade Name: Sedecal Digital Radiographic Upgrade Model SDRI-T Classification Name: Stationary x-ray system Common/Usual Name: Stationary x-ray system Regulation Number: 21 CFR 892.1680 Product Code: MQB)
- 3. Equivalent legally marketed device: This device uses the same digital x-ray panels as: Meridian Medical Universal Digital Interface UDI 1717. K112527 OR Meridian Medical Universal Digital Interface Wireless - UDI 1417W, KII11305 and uses the same software as the Medicatech Krystalrad 660, K 1 1 2 1 32.
- 4. Description of the Device: This Digital Radiographic Upgrade is intended for those radiographic examination rooms where the X-rav image receptors used are Cassette with Film or CR. This upgrade allows to acquire digital medical diagnostic X-ray images and transfer the images to hardcopy, softcopy, and archive devices on the same network. Some functions allowed with the Digital Radiography Operator Console (DROC) software:
- Add new patients to the system, enter information about the patient and physician that will be . associated with the digital radiographic images.
- . Edit existing patient information.
- Emergency registration and edit Emergency settings. .
- Pick from a selection of procedures, which defines the series of images to be taken. .
- Adjust technique settings before capturing the X-ray image. .
- Preview the image, accept or reject the image entering comments or rejection reasons to the . image. Accepted images will be sent to the selected output destinations.
- . Save an incomplete procedure, for which the rest of the exposures will be made at a later time.
- Close a procedure when all images have been captured. .
- . Review History images. resend and reprint images.
- Re-exam a completed patient. t
- . Protect patient records from being deleted by the system.
- . Delete an examined Study with all images being captured.
- Edit user accounts. .
- Check statistical information. .
- Image QC. �
- Image stitching. .

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- 5. Indications for Use (intended use) Sedecal Digital Radiographic Upgrade Model SDRU intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. The kit allows imaging of the skull, chest, shoulders, spine. abdomen, pelvis. and extremities.
- 6. Technological Characteristics: This device has the same technological characteristics (i.e., design, material, chemical composition, energy source) as the predicate devices. Specifications are for all intents and purposes identical. This submission represents the combination of two cleared devices: Software, and Digital X-Ray panel.
- 7. Discussion of the nonclinical and clinical tests in the premarket notification submission for a determination of substantial equivalence: We performed electrical safety (IEC 60601-1). electromagnetic compatibility testing, (IEC 60601-1-2), software validation testing, Test images were acquired and evaluated based on the FDA Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices. Clinical testing is not required because the digital panel was already cleared but images were acquired for verification/validation purposes. They were evaluated and found to be of good diagnostic quality.
- 8. Conclusion. Based on the results of the nonclinical tests (that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed devices) we conclude that this new digital x-ray upgrade kit is safe and effective as the predicates identified in paragraph (3). Furthermore, the materials and construction methods are nearly identical to the predicate.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 18, 2013

SEDECAL SA % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25TH STREET NW BUFFALO MN 55313

Re: K130883

Trade/Device Name: Sedecal Digital Radiographic Upgrade Model SDRU-T Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: March 28, 2013 Received: March 29, 2013

Dear Mr. Job:

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); medical device reporting (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Job

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Jaminghi. Messa

Janine M. Morris 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): K130883

Device Name: SEDECAL DIGITAL RADIOGRAPHIC UPGRADE. Model: SDRU-T

Indications for Use:

Sedecal Digital Radiographic Upgrade Model SDRU-T is intended for digital image capture use in general radiographic examinations, wherever conventional screenfilm systems may be used, excluding fluoroscopy, angiography and mammography. The kit allows imaging of the skull, chest, shoulders, spine. abdomen, pelvis. and extremities.

Prescription Use _ X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Remington. Press

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

:

510(k)

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