(36 days)
Not Found
No
The document does not mention AI, ML, or any related concepts like deep neural networks, training sets, or performance metrics typically associated with AI/ML algorithms. The description focuses on the hardware and basic functionality of a mobile X-ray unit.
No.
The device is described as a Digital Radiographic System intended for taking diagnostic radiographic exposures, which is for imaging purposes, not for treating diseases or conditions.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the system is "intended for use... for taking diagnostic radiographic exposures." This directly indicates its role in obtaining information used for diagnosis, even though it doesn't process or interpret the images itself.
No
The device description clearly states it is a "mobile x-ray unit" and mentions a "battery powered version" with "motor drive," 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 done outside of the body (in vitro).
- Device Function: The provided description clearly states that this device is a "Digital Radiographic System" and a "mobile x-ray unit." It is used to take "diagnostic radiographic exposures" of various body parts. This involves generating images of the internal structures of the body while the device is applied to the patient.
Therefore, since the device operates by applying radiation to the patient's body to create images and does not involve testing samples taken from the body, it falls under the category of an in vivo diagnostic imaging device, not an in vitro diagnostic device.
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 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
90 IZL, 90 MQB
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.
Mentions image processing
Not Found
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; patient's bed, first aid, and emergency, orthopedics, pediatric, and operating theater.
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 and test laboratory results 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)
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
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:
人
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- 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
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- 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.
-
- 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.
-
- 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.
1
| Characteristic | Sedecal Easy Moving
K012663 | Sedecal Easy Moving
Digital K043002 | Sedecal Mobile (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 | SAME |
| Configuration | Battery operated mobile | SAME | SAME |
| Performance
Standard | 21 CFR 1020.30 | SAME | SAME |
| Generator | High frequency made
by Sedecal | SAME | SAME |
| Generator power
levels | 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 or
digital models available) |
| Electrical safety | Electrical Safety per
IEC-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.
2
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.
3
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:
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.
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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