(149 days)
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No
The device description focuses on the refurbishment and replacement of existing hardware components of a C-arm system, with no mention of software algorithms, image processing beyond basic calibration, or any terms related to AI or ML.
No
The device is an OEC 902 C-Arm, which is an imaging device used to provide X-ray images, not to treat a condition or disease. The description indicates it's composed of an X-Ray Generator, Control Panel, and Image Intensifier and CCD Camera system, all components of an imaging system. It also lists predicate devices, OEC 901 and OEC 902, which are known imaging devices.
Yes
Explanation: The device is an X-ray C-Arm, which is used for medical imaging. Medical imaging devices are inherently diagnostic as they provide visual information of internal body structures to aid in diagnosis.
No
The device description explicitly details modifications and replacements of hardware components of an existing C-Arm system, including the frame, generator, control panel, wheels, motor drive assemblies, electronic systems, image intensifier, and CCD camera system. This indicates it is a hardware device with potential software components, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- No mention of in vitro testing: The description focuses entirely on the modification and refurbishment of an X-ray C-Arm system used for imaging the human body. There is no mention of analyzing samples (like blood, urine, or tissue) outside of the body, which is the core characteristic of an IVD.
- Imaging modality is X-ray: X-ray is an in vivo imaging modality, meaning it is used to visualize structures within a living organism. IVDs are used for in vitro analysis.
- Device description aligns with imaging equipment: The description details components like the C-Arm frame, X-Ray Generator, Image Intensifier, and CCD Camera, all of which are standard components of medical imaging systems, not IVDs.
Therefore, based on the provided text, this device is a refurbished and modified medical imaging device, not an IVD.
N/A
Intended Use / Indications for Use
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Product codes (comma separated list FDA assigned to the subject device)
OXO
Device Description
The OEC 902 C-Arm frame, X-Ray Generator, X-Ray Control, Control Panel, Electrical Systems remain the same. Imaging Services, Inc. takes an OEC 902 and repaints it. We repair all mechanical brakes, replace the wheels with the new wheels rated for a greater weight, repair or replace motor drive assemblies with original or comparable replacement parts, repair all electronic systems, then calibrate the X-Ray generator to manufacture specifications using the OEC 902 Service Manual. Then we add a new 9/6 Image Intensifier and CCD Camera system. The CCD Camera System is calibrated to North American Imaging and Imaging Services Specifications. The ABS system utilizes original manufacturer's specifications, wiring and its electronic path remains the same.
The wiring of the CCD Camera system uses original wires provided by the original camera system which was deinstalled. The interface between the C-Arm and monitor cart. also utilizes existing wiring as well as spares provided by OEC when the unit was originally manufactured.
Imaging Services, Inc. then tests the system to comply with all Federal, State and BRH standards. In no way does the final product effect the original X-Ray control as designed by OEC . As stated above, we continue to utilize the original C-Arm Generator and Control System as intended by OEC Diasonics.
This upgraded version is designed only to provide a refurbished C-Arm with state of the art image quality All of the results from this upgrade improve the final product delivered to the customer. Also with the CCD Camera upgrade and new Image Intensifier, the dynamic range of the C-Arm is increased to new C-Arm standards. Patient dose is decreased by improving dynamic range and contrast/resolution is increased by the CCD Camera upgrade.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Image intensified fluoroscopic x-ray system
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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
APR 1 2 1996
955575|
Premarket Notification 510(k) Summary
[As required by 21CFR 807.92(a)]
Trade Name: Nasa II C-arm Common Name: C-arm Classification Name: Mobile X-ray System
I certify that, in my capacity as President of Imaging Services, Inc., The Nasa II C-arm is equivalent to the OEC 901 and 902 model C-arms. Mechanically and electrically the Nasa II C-arm is as safe and effective as the OEC models 901 and 902. The difference between OEC's above models and the Nasa II is the imaging chain or CCD Camera and Camera Control Unit. The intended use for the Nasa II has not change and is not marketed as such.
The OEC 902 C-Arm frame, X-Ray Generator, X-Ray Control, Control Panel, Electrical Systems remain the same. Imaging Services, Inc. takes an OEC 902 and repaints it. We repair all mechanical brakes, replace the wheels with the new wheels rated for a greater weight, repair or replace motor drive assemblies with original or comparable replacement parts, repair all electronic systems, then calibrate the X-Ray generator to manufacture specifications using the OEC 902 Service Manual. Then we add a new 9/6 Image Intensifier and CCD Camera system. The CCD Camera System is calibrated to North American Imaging and Imaging Services Specifications. The ABS system utilizes original manufacturer's specifications, wiring and its electronic path remains the same.
The wiring of the CCD Camera system uses original wires provided by the original camera system which was deinstalled. The interface between the C-Arm and monitor cart. also utilizes existing wiring as well as spares provided by OEC when the unit was originally manufactured
Imaging Services, Inc. then tests the system to comply with all Federal, State and BRH standards. In no way does the final product effect the original X-Ray control as designed by OEC . As stated above, we continue to utilize the original C-Arm Generator and Control System as intended by OEC Diasonics.
This upgraded version is designed only to provide a refurbished C-Arm with state of the art image quality All of the results from this upgrade improve the final product delivered to the customer. Also with the CCD Camera upgrade and new Image Intensifier, the dynamic range of the C-Arm is increased to new C-Arm standards.
1
Patient dose is decreased by improving dynamic range and contrast/resolution is increased by the CCD Camera upgrade.
Imaging Services, Inc. follows all guidelines of Good Manufactures practices including serial number and calibration tracking and verification. All calibration equipment used by Imaging Services, Inc. is traceable to the National Bureau of Standards. Calibration specifications guidelines for x-ray control and generation are followed from the original Manufacturer's Service Manual. Imaging Chain Calibration Specifications/ Guidelines are followed by North American Imaging and Imaging Services, Inc. standards.
This product provides a high end, low cost refurbished system to customers who cannot afford a new C-Arm, while maintaining superior image quality as with a new C-Arm.
Imaging Services, Inc. 1037 N. Lima Street Burbank, CA 91505 (800)900-9729 (818)841-8862 Fax
Signature
Dean N. Janes President
2/14/96
(Premarket Notification [510(k)] number)
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Image /page/2/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 eagle with its head turned to the right. The eagle's body is composed of three curved lines that suggest movement or flight. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Mr. Dean N. Janes President Imaging Services, Inc. 1037 North Lima Street BURBANK CA 91505
NOV 1 7 2011
Re: K955251
Trade/Device Name: OEC 902 Nasa II CCD C-arm Regulation Number: 21 CFR 892.1650 Regulation Name: Image intensified fluoroscopic x-ray system, mobile Regulatory Class: II Product Code: OXO Dated: February 15, 1996 Received: February 20, 1996
Dear Mr. Janes:
This letter corrects our substantially equivalent letter of April 12, 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21
3
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 (OS) 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/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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely Yours,
Maha DÓA 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