(17 days)
Not Found
No
The document does not mention AI, ML, or any related terms, and the device description focuses on standard radiographic technology and integration of existing components.
No
The device is described as taking "diagnostic radiographic exposures" and does not mention treating or preventing any medical conditions.
Yes
The "Intended Use / Indications for Use" section states that the device is intended "for taking diagnostic radiographic exposures."
No
The device description explicitly states it is a mobile X-ray unit which operates from AC or batteries and utilizes high frequency inverters, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is performed outside of the body (in vitro).
- Device Function: The provided description clearly states that this device is a Mobile Radiographic System with Digital Detector. Its function is to take diagnostic radiographic exposures (X-rays) of various body parts. This is an imaging modality that works on the patient's body, not on specimens taken from the body.
- Intended Use: The intended use is for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. This involves imaging the internal structures of the body directly.
Therefore, based on the provided information, this device falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Sedecal Mobile Radiographic Systems with Digital Detector 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.
Product codes (comma separated list FDA assigned to the subject device)
IZL, MQB
Device Description
Sedecal Mobile X-ray Units with Digital Detector arc mobile units which operate from 120 or 220 V 50-60~ AC or batteries. The units utilize high frequency inverters. The usual safety precautions regarding the use of xrays must be observed by the operator. This modified device combines two FDA cleared devices by way of a common user interface, a color LCD touch panel. The X-Ray generator is controlled by a serial port on the CANON CXDI-50G.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic
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)
The results of bench, user, and standards testing indicates that the new device is as safe and effective as the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Koysaooz
NOV 1 8 2004
| 510(k) Summary | ||||
|---|---|---|---|---|
| SEDECAL SA | ||||
| Pelaya 9- Poligono Industrial Rio De | ||||
| Janeiro | ||||
| 28110-Algete | ||||
| Madrid Spain | ||||
| Tel (34) 91-628 0544/91-628 1592 | ||||
| Fax (34) 91-628 0574 | ||||
| (Foreign Manufacturer) | SEDECAL USA, Inc. | |||
| 2910 N. Arlington Heights Rd. | ||||
| Arlington Heights Illinois 60006 | ||||
| Tel 847-394-6960 | ||||
| Fax 847-394-6966 | ||||
| (Initial Importer) | ||||
| Contact: Devan Moser |
EXHIBIT 2
October 22, 2004
-
- Identification of the Device: Proprietary-Trade Name: Sedecal Mobile Radiographic Systems with Digital Detector Classification Name: Mobile X-ray system, Product Codes Product Code 90 IZL and MOB Common/Usual Name: General purpose mobile diagnostic X-ray Unit.
-
- Indications for Use (intended use) The Sedecal Mobile Radiographic Systems with Digital Detector 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.
-
- Description of the Device: Sedecal Mobile X-ray Units with Digital Detector arc mobile units which operate from 120 or 220 V 50-60~ AC or batteries. The units utilize high frequency inverters. The usual safety precautions regarding the use of xrays must be observed by the operator. This modified device combines two FDA cleared devices by way of a common user interface, a color LCD touch panel. The X-Ray generator is controlled by a serial port on the CANON CXDI-50G.
-
- Safety and Effectiveness, comparison to predicate device. The results of bench, user, and standards testing indicates that the new device is as safe and effective as the predicate devices.
1
| Characteristic | Model Mobile
K012663 (Two
models) | Canon CXDI-50G
Digital
Radiography,
K031447 | Sedecal Mobile X-
ray Units with Detector
(Combination
device) |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Intended Use: | Mobile general purpose
diagnostic X-ray unit | SAME | SAME |
| Size | | Imaging Area 14 x 17 | SAME (Combined
device) (A stand has
been added) |
| Weight (battery version) | 1045 lb | 10.6 lb | 964 lb. |
| Energy Source: | 90 to 285 VAC (50-60
Hz) or Batteries | 100V, 120V,
230/240V(50/60Hz) | SAME (Combined
device) |
| User Interface | Up-Down pushbuttons
for kVp and mAs. KVp
adjustable in I kVp
steps | Software Driven Touch
Panel LCD | Software Driven Touch
Panel LCD (Combined
device) |
| Power | 20 or 30 kW | N/A | Models up to 50 kW |
| Exposure times | 0.001 - 8 SECONDS
$\pm$ (1%+0.1 MS) | N/A | SAME (Combined
device) |
| Ma. | 10, 12.5, 16, 20, 25, 32,
40, 10, 12.5, 16, 20, 25,
32, 40, 50, 64, 80, 100,
125, 160, 50, 64, 80,
100, 125, 160, 200, 250,
320 200, (400, and 500
on 30 kw unit)
$\pm$ (5%+0.1 MA) | N/A | SAME (Combined
device) |
| kVp | 40 to 150 in 1 kVp steps
(30 kw unit) | N/A | SAME (Combined
device) |
| Resolution | N/A | 160 x 160 microns pixel
pitch, with
approximately 6 million
pixels and 4,096 gray
scale contrast | SAME (Combined
device) |
| Method of Control | Dedicated Touch Panel | Software Driven Touch
Panel LCD | SAME as CANON. Or
original Dedicated
Touch Panel |
| Performance Standard | 21 CFR 1020.30 | SAME | SAME |
| Electrical safety: | IEC 60601-1 | SAME | SAME |
6. Substantial Equivalence Chart, The Sedecal Portable X-ray Units with Detector
7. Conclusion
After analyzing bench, user, and standards testing data, it is the conclusion of Sedecal that the Sedecal Mobile X-ray Units with Digital Detector are as safe and effective as the predicate devices, have few technological differences, and have no new indications for use, thus rendering them substantially equivalent to the predicate devices.
2
Image /page/2/Picture/0 description: The image shows the logo of the Department of Health & Human Services. The logo consists of a symbol on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The symbol is a stylized representation of a human figure, and the text is in a bold, sans-serif font.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
SEDECAL SA % Mr. Daniel Kamm Regulatory Engineer Kamm & Associates PO Box 7007 DEERFIELD IL 60015
AUG 23 2013
Re: K043002
Trade/Device Name: Sedecal Mobile X-Ray Units with Digital Detector Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL and MQB Dated: October 27, 2004 Received: November 1, 2004
Dear Mr. Kamm:
This letter corrects our substantially equivalent letter of November 18, 2004.
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 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 Parts 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 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 Parts 801 and 809), please contact the Office of In Vitro 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 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morri 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):_____________________________________________________________________________________________________________________________________________________
Device Name: Sedecal Mobile X-Ray Units with Digital Detector
Indications For Use:
The Sedecal Mobile Radiographic Systems with Digital Detector 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.
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)
David A. Bergman
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(Division Sign-Off) Division of Reproductive, Ab and Radinlogical Devices 5 1()(k) Number