(26 days)
Not Found
No
The description focuses on standard image processing techniques and hardware components, with no mention of AI or ML.
No.
This device is an x-ray system used for imaging and diagnostic purposes, not for providing therapy or treatment. Its intended uses involve visualizing anatomical structures and guiding clinical procedures, not directly treating a disease or condition.
No
Explanation: The device is an x-ray system used for imaging, not for diagnosing conditions. Its primary function is to provide visual information (images) that can be used by a healthcare professional for diagnosis, but the device itself does not perform the diagnosis.
No
The device description clearly states it is a mobile x-ray C-arm system consisting of multiple hardware components including a generator, X-ray tube, image intensifier, TV camera, etc. While it includes digital memory and image processing capabilities, it is fundamentally a hardware device with integrated software.
Based on the provided text, the Siremobil Compact is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Siremobil Compact is an X-ray system that directly images the inside of the body.
- The intended use and device description clearly state that the Siremobil Compact is an imaging system used for clinical procedures involving direct visualization of anatomical structures. This is the function of an in vivo imaging device, not an in vitro diagnostic device.
- There is no mention of analyzing biological samples or performing tests on specimens.
Therefore, the Siremobil Compact is an in vivo imaging device, not an IVD.
N/A
Intended Use / Indications for Use
The Siremobil Compact is a mobile x-ray system intended for use in the Operating room, Traumatology, Endoscopy, Intensive Care Station, Pediatrics, Ambulatory patient care and in Veterinary Medicine. The Siremobil Compact can operate in four different modes, Digital Radiography, Fluoroscopy, Pulsed Fluoroscopy and cassette exposures which are necessary in performing wide variety of clinical procedures, such as intraoperative bile duct display, fluoroscopic display of a intra-medullary nail implants in various positions, low dose fluoroscopy in pediatrics, fluoroscopic techniques utilized in pain therapy and positioning of catheters and probes.
Product codes
OXO
Device Description
The Siremobil Compact is a mobile x-ray C-ram which consists of a high frequency generator, X-ray tube assembly, image intensifier, TV camera, film cassette attachment, Laser light localizers, electronics cabinet and a monitor trolley which consists of the digital memory device, image monitor(s), and user interface. The Siremobil Compact is designed to meet the space and clinical requirements of the clinical environments identified below.
The Siremobil Compact is designed for easy maneuverability, durability and high efficiency and performance. The system operation is designed to provide the user with an ergonomic clinically optimized interface. The Siremobil Compact can operate in three modes, Fluoroscopy with Last Image Hold, Pulsed Fluoroscopy with Last Image Hold and Digital Radiography, The user can process the images utilizing such techniques as recursive filtration, summation or spatial noise suppression, spatial frequency filtration, motion detector, edge enhancement, and contrast enhancement.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray Imaging
Anatomical Site
Not Found
Indicated Patient Age Range
Pediatrics
Intended User / Care Setting
Operating room, Traumatology, Endoscopy, Intensive Care Station, Pediatrics, Ambulatory patient care and in Veterinary Medicine. Trained healthcare professional.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K913525, K910902, K910115, K926056
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
SIEMENS
3 1996
510 (k) SUMMARY
•
I. GENERAL INFORMATION: Establishment:
• Address:
· Registration Number:
186 Wood Avenue South Iselin, NJ. 08830
Siemens Medical Systems, Inc.
2240869
Kathleen Rutherford Manager, Regulatory Submissions Telephone: (908) 321- 4779 TELEFAX: (908) 321 - 4841
Date of Summary Preparation:
Device Name: · Trade Name:
·Contact Person:
Siremobil Compact
·Common Name:
· Classification Name:
Mobile X-ray System
Mobile X-ray System
Class II
·Classification:
Performance Standards:
21 CFR, Subchapter I
All system components to which the above standard applies are certified to conform with 21 CFR subchapter J
SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING THE II. SUBSTANTIAL EQUIVALENCE DETERMINATION.
Device Description:
The Siremobil Compact is a mobile x-ray C-ram which consists of a high frequency generator, X-ray tube assembly, image intensifier, TV camera, film cassette attachment, Laser light localizers, electronics cabinet and a monitor trolley which consists of the digital memory device, image monitor(s), and user interface. The Siremobil Compact is designed to meet the space and clinical requirements of the clinical environments identified below.
Siemens Medical Systems, Inc.
186 Wood Avenue South Tel: (908) 321-4500 Iselin, NJ 08830 Fax: (908) 494-2250
1
SIEMENS
The Siremobil Compact is designed for easy maneuverability, durability and high efficiency and performance. The system operation is designed to provide the user with an ergonomic clinically optimized interface. The Siremobil Compact can operate in three modes, Fluoroscopy with Last Image Hold, Pulsed Fluoroscopy with Last Image Hold and Digital Radiography, The user can process the images utilizing such techniques as recursive filtration, summation or spatial noise suppression, spatial frequency filtration, motion detector, edge enhancement, and contrast enhancement.
Intended Use:
The Siremobil Compact is a mobile x-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive Care Station, Pediatrics, Ambulatory patient care and in Veterinary Medicine. The Siremobil Compact can operate in four different modes, Digital Radiography, Fluoroscopy, Pulsed Fluoroscopy and cassette exposures which are necessary in performing wide variety of clinical procedures, such as intraoperative bile duct display, fluoroscopic display of a intra-medullary nail implants in various positions, low dose fluoroscopy in pediatrics, fluoroscopic techniques utilized in pain therapy and positioning of catheters and probes.
Technological Characteristics:
The Siremobil Compact is designed for an optimal range of movement. The rotational, orbital, and angulation movement ranges for the C-arm are as follows: ± 12.5 °, 125° (-35 to +90) orbital movement and ± 190° angulation. The horizontal and vertical movement of the C-arm is optimized for use in clinical applications. The horizontal travel is 20 cm (7.9") and the vertical travel is 45 cm (17.7"). The large C-arm depth, 66 cm (29"), provides the user with excellent patient access during examinations.
General Safety and Effectiveness Concerns:
Instructions for use are included within the device labeling and the information provided will enable the trained healthcare professional to operate the device in a safe and efficacious manner. Furthermore the operators are health care professionals familiar with and responsible for the X-ray examinations to be performed. To minimize electrical, mechanical and radiation hazards, Siemens adheres to recognized and established industry practice, and all equipment is subject to final performance testing.
2
SIEMENS
Substantial Equivalence:
The Siremobil Compact, Mobile X-ray System, has similar technological characteristics and intended uses as the predicate devices described in the Equivalency Information section of this premarket notification. Also, the Laser Targeting Devices (one unit attached to the image intensifier and one unit to attached to the x-ray tube) configured with the Siremobil Compact are the same as the device currently configured with the commercially available Siremobil 2000.
Siemens Medical Systems, Inc. believes that the Siremobil Compact, the subject of this premarket notification, is substantially equivalent to the following medical devices currently in commercial distribution.
Model
Company
FDA K-Number
Siremobil 2000 Stenoscop 6000/9000 BV 29 Series 9600
Siemens Medical Systems, Inc. General Electric, Inc. Philips, Inc. OEC, Inc.
Kathleen Rutherford
Kathleen Rutherford Manager, Regulatory Submissions
8/7/96
Date
Date
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, with three overlapping profiles facing to the right. The profiles are arranged in a way that suggests movement or progress. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
NOV 17 2011
Ms. Kathleen Rutherford Manager, Regulatory Submissions Siemens Medical Systems, Inc. 186 Wood Avenue South ISELIN NJ 08830
Re: K963093
Trade/Device Name: Siremobil Compact Mobile X-ray System Regulation Number: 21 CFR 892.1650 Regulation Name: Image intensified fluoroscopic x-ray system, mobile Regulatory Class: II Product Code: OXO Dated: August 7, 1996 Received: August 8, 1996
Dear Ms. Rutherford:
This letter corrects our substantially equivalent letter of September 3, 1996.
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 (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. Please Note: CDRH does not evaluate information related to contact liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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
4
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/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.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely Yours,
ullD'O'Rhm For
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Attachment L: Indications for Use
963093 510(k) Number (if known): Siremobil Compact Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Siremobil Compact is a mobile x-ray system intended for use in The Sitentoon Compact 22 - 2016 - 11:20 PM Intensive Care Station, Pediatrics, Operating Toom, Tradikator 87.
Ambulatory patient care and in Veterinary Medicine. The Siremobil Compact Amoulatory patient cases.
can operate in four different modes, Digital Radiography, Fluoroscopy and can operate in four aniesesses exposure which are necessary in performing wide variety of clinical procedures, such as intraoperative bile duct display, wide variety of cimied positions pail implant in various positions, low huoroscopic as pay in pediatrics, fluoroscopic techniques utilized in pain therapy and positioning of catheters and probes.
Concurrence of the CDRH, Office of Device Evaluation (ODE)
Yamil. U. Lession
(Division Sign Off)
(Division Sign-Off)
Division of Reproductive, Abdoirinal, ENT,
and Radiological Devices
510(k) Number K963093
OR
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use
Siremobil Compact 510 (k) Premarket Notification August 6, 1996