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 skull, 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 Description

Easy Moving Plus is a mobile x-ray unit that covers, with a wide 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. The cordless Easy Moving "B" (battery powered version) combines stand alone feature for exposures with battery assisted motor drive for the greatest ease in imaging.

AI/ML Overview

The provided text is a 510(k) summary for the Sedecal Easy Moving Plus Mobile X-Ray System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel device. Therefore, many of the requested categories about specific performance metrics, ground truth, and expert studies are not applicable or explicitly stated in this type of submission.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission for substantial equivalence to predicate devices, there isn't a table of specific acceptance criteria in the sense of quantitative performance targets for a new therapeutic or diagnostic algorithm. Instead, the "acceptance criteria" are implied by demonstrating that the new device's characteristics are either identical to or non-inferior to the predicate devices, particularly regarding safety and effectiveness.

The document directly compares the Sedecal Easy Moving Plus to its predicate devices, K012663 (Easy Moving film) and K043002 (Easy Moving Digital). The performance is effectively assessed by establishing that the new device shares the same intended use, configuration, relevant performance standards, and similar technical specifications (e.g., generator type, collimator, electrical safety).

Characteristic	Predicate Device K012663 (Easy Moving film)	Predicate Device K043002 (Easy Moving Digital)	Sedecal Easy Moving Plus (K090322)
Intended Use	Same as indicated below	Same as indicated below	Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, 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.
Configuration	Battery operated mobile	Battery operated mobile	Battery operated mobile
Performance Standard	21 CFR 1020.30	21 CFR 1020.30	21 CFR 1020.30
Generator	High frequency made by Sedecal	High frequency made by Sedecal	High frequency made by Sedecal
Generator Power	20 or 30 kw (2 models)	16 to 50 kw (4 models)	20 to 50 kw (4 models)
Collimator	Ralco R221 DHHS	Ralco R221 DHHS	Ralco R221 DHHS
Image Acquisition	Film	Digital CANON 50G	CANON 50G (Film or digital models available)
Electrical Safety	Electrical Safety per IEC-60601. UL listed	Electrical Safety per IEC-60601. UL listed	Electrical Safety per IEC-60601. UL listed

2. Sample Size Used for the Test Set and Data Provenance

This is not a study involving a "test set" in the context of an AI algorithm or a diagnostic test with patient data. The submission relies on bench and external laboratory testing to applicable standards, as stated in Section 5 and 7. The data provenance is not specified beyond "bench and external laboratory results," implying controlled engineering and electrical testing rather than clinical data from specific countries or patients.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. The study is not assessing a diagnostic or predictive device requiring expert-established ground truth from clinical cases. It's about the safety and performance of an X-ray system itself.

4. Adjudication Method for the Test Set

Not applicable, as there is no clinical "test set" requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size

Not applicable. This is a medical device clearance for an X-ray system, not a clinical study evaluating the effectiveness of human readers with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is an X-ray system, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this submission are the applicable performance standards (e.g., 21 CFR 1020.30 for performance standards for diagnostic X-ray systems and their major components; IEC-60601 for electrical safety). The device's compliance with these standards (through bench and laboratory testing) serves as the "ground truth" for its safety and effectiveness.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set.

Summary

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K090322

MAR 1 7 2009

510(k) Summary 510(k) Number K09 Sedecal, Inc. SEDECAL SA C/ Pelaya, 9 - 13 Pol. Ind. Río de Janeiro 28110 Algete, Madrid, España (Spain) Tel .- +34 91 6280544 Fax .- +34 91 6280574 Date Prepared: February 3, 2009 Mª Luisa Gómez de Agüero, Quality and Regulatory Manager Contact:

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1. Identification of the Device: Proprietary-Trade Name: Sedecal Easy Moving Plus (various models) Classification Name: Mobile x-ray system, Product Code 90 IZL and Solid State X-Ray Imager (Flat Panel/Digital Imager) 90 MQB, Common/Usual Name: Digital Mobile Diagnostic X-Ray System
1. Equivalent legally marketed devices: (all Sedecal made) K012663 Easy Moving (film), K043002 Easy Moving (digital).
1. Indications for Use (intended use) Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic exposures of the skull, 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.
1. Description of the Device: Easy Moving Plus is a mobile x-ray unit that covers, with a wide 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. The cordless Easy Moving "B" (battery powered version) combines stand alone feature for exposures with battery assisted motor drive for the greatest ease in imaging.
1. Safety and Effectiveness, comparison to predicate device. Bench and test laboratory results indicates that the new device is as safe and effective as the predicate devices.

Image /page/0/Picture/8 description: The image shows three different versions of a medical imaging device. The first device is labeled "Easy Moving (film) K012663", the second is labeled "Easy Moving Digital K043002", and the third is labeled "Modified: Easy Moving Plus". All three devices appear to be mobile X-ray machines, with variations in their design and features. The "Easy Moving Plus" version seems to be a more advanced or updated model compared to the other two.

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Characteristic	Sedecal Easy MovingK012663	Sedecal Easy MovingDigital K043002	Sedecal Mobile (variousmodels)
Intended Use:	Intended for use by aqualified/trained doctoror technician on bothadult and pediatricsubjects for takingdiagnostic radiographicexposures of the skull,spinal column, chest,abdomen, extremities,and other body parts.Applications can beperformed with thepatient sitting, standing,or lying in the prone orsupine position.	SAME	SAME
Configuration	Battery operated mobile	SAME	SAME
PerformanceStandard	21 CFR 1020.30	SAME	SAME
Generator	High frequency madeby Sedecal	SAME	SAME
Generator powerlevels	20 or 30 kw (2 models)	16 to 50 kw (4 models)	20 to 50 kw (4 models)
Collimator	Ralco R221 DHHS	SAME	SAME
Image acquisition	Film	Digital CANON 50G	CANON 50G (Film ordigital models available)
Electrical safety	Electrical Safety perIEC-60601. UL listed	SAME	SAME

6. Substantial Equivalence Chart

7. Conclusion

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 7 2009

Sedecal SA % Daniel Kamm, P.E. Principiel Consultant Kamm & Associates 333 Milford Rd DEERFIELD IL 60015

Re: K090322

Trade/Device Name: Sedecal Easy Moving Plus Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IXL Dated: February 5, 2009 Received: February 9, 2009

Dear Mr. Kamm:

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. Iisting 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 such 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.

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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; 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding os 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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	(240) 276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	(240) 276-0115
21 CFR 892.xxx	(Radiology)	(240) 276-0120
Other		(240) 276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry.suppot/index.html.

Sincerely yours,

Janine M. Morris

Acting Director. Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use 510(k) Number (if known): K09 (32

Device Name: Sedecal Easy Moving Plus

Indications For Use:

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 Device Evaluation (ODE)

tom nhan

(Division Sign-Off) Division of Reproductive, Abdominal and Radlological Devices 510(k) Number

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Regulation Number and Section

§ 892.1720 Mobile x-ray system.

(a)
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.(b)
Classification. Class II.