(429 days)
Not Found
No
The document does not mention AI, ML, deep learning, or any related terms in the device description, intended use, or performance studies. The focus is on the hardware (mobile x-ray unit, digital panels) and standard image processing and DICOM compatibility.
No
The device is described as a diagnostic radiographic system used for taking X-ray exposures to identify or visualize medical conditions, not to treat them.
No
Explanation: The device is an X-ray system used for taking diagnostic radiographic exposures, but it does not diagnose conditions itself. It provides images that a doctor or technician then uses for diagnosis.
No
The device description clearly states it is a "mobile x-ray unit" and mentions hardware components like "cordless units," "battery assisted motor drive," and "digital image acquisition panels." While it includes integrated software, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue). The intended use and device description clearly state that this system is used for taking radiographic exposures of the patient's body parts (skill, spinal column, chest, etc.).
- The input imaging modality is X-Ray. X-ray imaging is an in vivo diagnostic method, meaning it's performed on a living organism. IVD devices are in vitro, meaning they are used outside of the living organism.
The device is a Digital Radiographic System, which is a type of medical imaging device used for diagnostic purposes on the patient.
N/A
Intended Use / 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.
Product codes
IZL, MQB, LLZ
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
skull, spinal column, chest, abdomen, extremities, and other body parts
Indicated Patient Age Range
adult and pediatric subjects
Intended User / Care Setting
qualified/trained doctor or technician
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)
Bench, test laboratory results, and clinical image comparisons indicate that the new devices are as safe and effective as the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.- +34 91 6280544 Fax .- +34 91 6280574 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
-
- 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.
-
- 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)
-
- 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.
1
6. Substantial Equivalence Chart
| Characteristic | Sedecal Easy Moving
Digital K090322 | Sedecal Mobile Digital
Diagnostic X-Ray Systems
(various models) |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| 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 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. | SAME |
| Configuration | Battery or line operated
mobile | SAME |
| Performance
Standard | 21 CFR 1020.30 | SAME |
| Generator | High frequency made by
Sedecal | SAME |
| Generator power
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-
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.
2
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
3
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 (301) 796-5450. 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 (800) 638-2041 or (301) 796-7100 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
4
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
Page 1 of 1