SEDECAL MOBILE DIGITAL DIAGNOSTIC X-RAY

K101517 · Sedecal., Sa. · IZL · Aug 5, 2011 · Radiology

Device Facts

• Record ID: K101517
• Device Name: SEDECAL MOBILE DIGITAL DIAGNOSTIC X-RAY
• Applicant: Sedecal., Sa.
• Product Code: IZL · Radiology
• Decision Date: Aug 5, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1720
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skill, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.

Device Story

Mobile digital X-ray system for bedside, emergency, orthopedic, and operating theater use. Operated by qualified physicians or technicians. System utilizes high-frequency generator (20-50 kW) to produce X-ray exposures; digital image acquisition via Trixell or Varian flat-panel detectors. Battery-assisted motor drive facilitates transport. Integrated DICOM-compatible software manages image acquisition and processing. Healthcare providers view images on connected workstations to support clinical diagnosis and decision-making. Benefits include portable, high-quality diagnostic imaging for patients unable to be transported to radiology departments.

Clinical Evidence

Bench testing, laboratory results, and clinical image comparisons were performed. No specific clinical trial data or statistical metrics (sensitivity/specificity) provided in the summary; equivalence established via comparative analysis of performance standards and image quality.

Technological Characteristics

Mobile X-ray unit; high-frequency generator (20-50 kW); Trixell or Varian digital flat-panel detectors; battery-assisted motor drive; DICOM-compatible software; electrical safety per IEC-60601; Ralco R221 collimator.

Indications for Use

Indicated for adult and pediatric patients requiring diagnostic radiographic imaging of the skull, spine, chest, abdomen, and extremities. Procedures performed with patient in sitting, standing, prone, or supine positions.

Regulatory Classification

Identification

A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• Easy Moving Plus Mobile X-Ray (K090322)
• DICOMPACS, MODEL 5.2, DICOMPACS DX-R, MODEL I.4, GEHM UND REHBEIN GMBH (K091364)

Submission Summary (Full Text)

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## 510(k) Summary 510(k) Number K10 1517 Sedecal, Inc. SEDECAL SA C/ Pelaya, 9 - 13 Pol. Ind. Río de Janeiro 28110 Algete, Madrid, España (Spain) Tel.- [phone] Fax .- [phone] Date Prepared: May 27, 2010 Contact: Mª Luisa Gómez de Agüero, Quality and Regulatory Manager

- l . Identification of the Device: Proprietary-Trade Name: Sedecal Mobile Digital Diagnostic X-Ray Systems (various models) Classification Name: Mobile x-ray system, Product Code IZL and Solid State X-Ray Inager (Flat Panel/Digital Imager) MQB, with Image Processing Software Code LLZ. Common/Usual Name: Digital Mobile Diagnostic X-Ray System
- 2. Equivalent legally marketed devices: K090322 Easy Moving Plus Mobile X-Ray, and K091364, DICOMPACS, MODEL 5.2, DICOMPACS DX-R, MODEL I.4, GEHM UND REHBEIN GMBH
- 3. Indications for Use (intended use) Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skill, spinal column, chest, abdomen, extremities, and other body parts. Applications on the performed with the patient sitting, standing, or lying in the prone or supine position.
- 4. Description of the Device: Sedecal Digital Mobiles (various models) are mobile x-ray units that covers, with a range of models, all the specific needs of any radiographic examination at the patient's bed, first aid, and emergency, orthopedics, pediatric, and operating theater. These cordless units combine stand alone feature for exposures with battery assisted motor drive for the greatest ease in imaging. Two different brands of digital image acquisition panels are offered: Trixell and Varian. Integrated software for Dicom compatibility is also included. Model list: For Varian: SM-20HF-B-D-V, SM-32HF-B-D-V, SM-40HF-B-D-V, SM-50HF-B-D-V For Trixell: SM-20HF-B-D-T, SM-32HF-B-D-T, SM-40HF-B-D-T, SM-50HF-B-D-T, SM-50HF-B-D-T, The numeric value indicates the generator power in kW. All units are supplied with Dicom software. (K091364)
- 5. Safety and Effectiveness, comparison to predicate device. Bench, test laboratory results, and clinical image comparisons indicate that the new devices are as safe and effective as the predicate devices.

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## 6. Substantial Equivalence Chart

| Characteristic | Sedecal Easy Moving<br>Digital K090322 | Sedecal Mobile Digital<br>Diagnostic X-Ray Systems<br>(various models) |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| Intended Use: | Intended for use by a<br>qualified/trained doctor or<br>technician on both adult<br>and pediatric subjects for<br>taking diagnostic<br>radiographic exposures of<br>the skull, spinal column,<br>chest, abdomen,<br>extremities, and other<br>body parts. Applications<br>can be performed with the<br>patient sitting, standing, or<br>lying in the prone or<br>supine position. | SAME |
| Configuration | Battery or line operated<br>mobile | SAME |
| Performance<br>Standard | 21 CFR 1020.30 | SAME |
| Generator | High frequency made by<br>Sedecal | SAME |
| Generator power<br>levels | 20 to 50 kw (4 models) | 20 to 50 kw (8 models) |
| Collimator | Ralco R221 DHHS | SAME |
| Image acquisition | Digital CANON 50G | Trixell or Varian |
| Electrical safety | Electrical Safety per IEC-<br>60601. UL listed | SAME |

## 7. Conclusion

After analyzing bench, laboratory, and clinical testing to applicable standards, it is the conclusion of Sedecal Inc the modified Sedecal Mobile X-Ray Systems are as safe and effective as the predicate devices, have few technological differences, and has no new indications for use, thus rendering them substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle's head is facing right, and its feet are visible below. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

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

SEP 1 2 2013

SEDECAL SA % Mr. Danial Kamm, P.E. Regulatory Engineer, Submission Correspondent Kamm & Associates 8870 Ravello Court NAPLES FL 34114

Re: K101517

Trade/Device Name: Sedecal Mobile Digital Diagnostic X-Ray Systems (various models) Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL and MQB Dated: June 15, 2011 Received: June 17, 2011

Dear Mr. Kamm:

This letter corrects our substantially equivalent letter of August 9, 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 (sec 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 Part 801 and 809); medical device reporting (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 devices to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 809), please contact the Office of In Viro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse cvents under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/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.lda.gov/cdrh/industry/suport/index.html.

Sincerely yours.

Sm
for

Janine M. Morris 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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## Indications for Use

510(k) Number (if known): K10 ประ 17

Device Name: Sedecal Mobile Digital Diagnostic X-Ray Systems (various models)

Indications For Use:

These Digital Radiographic Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skill, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.

Prescription Use _X (Part 21 CFR 801 Subpart D) .

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In-vitro Diagnostics (OIVD)

Mary Sootel

Division of Redinton

510K KL01517

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