(87 days)
K/DEN number: Not Found
Not Found
No
The summary describes a standard fluoroscopic x-ray system with image processing and storage, but there is no mention of AI, ML, or related concepts. The description of the device components and intended use aligns with traditional medical imaging technology.
No
The device is an imaging system used for diagnosis and guidance during surgical procedures, not for treating diseases or conditions.
No
The device is described as an image-intensified fluoroscopic x-ray system intended for use in general surgical and interventional procedures. Its function is to provide real-time imaging during procedures, not to diagnose medical conditions.
No
The device description clearly outlines multiple hardware components including a mobile C-Arm with an image intensifier, x-ray generator, x-ray tube, and a monitor cart with TV monitors. While it includes an "image digital processing and storage system," this is part of a larger hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the system is for "mobile image-intensified fluoroscopic x-ray systems, intended for use in general surgical procedures... or other interventional procedures." This describes a device used on a patient for imaging during medical procedures.
- Device Description: The components listed (C-Arm, image intensifier, x-ray generator, x-ray tube, monitors, image processing) are all typical of medical imaging equipment used for visualizing internal structures of the body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health. There is no mention of specimen analysis or laboratory use in the provided text.
Therefore, the ACCENT system is a medical imaging device used for in-vivo procedures, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ACCENT systems are mobile image-intensified fluoroscopic x-ray systems, intended for use in general surgical procedures such as orthopedics, traumatology, visceral surgery, pacemaker implants, urology, etc. or other interventional procedures.
Product codes
OXO
Device Description
The ACCENT system is composed of: a mobile C-Arm that includes: an image intensifier with CCD video camera . an x-ray generator and controller an x-ray tube mounted in the same housing as the x-ray generator a beam-limiting device optional: a Laser beam alignment device . optional: a dose area product meter and display . and a monitor cart that includes: TV monitors an image digital processing and storage system, may be of different models . optional: VCR and video printers .
Mentions image processing
an image digital processing and storage system
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Image-intensified fluoroscopic x-ray
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
General surgical procedures
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)
STENOSCOP 2, Model 6000, STENOSCOP 2, Model 9000
Reference Device(s)
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
§ 892.1650 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
K980 322
APR 2 4 1998
510(k) SUMMARIES OF SAFETY AND EFFECTIVENESS
IDENTIFICATION OF THE PRODUCT
ACCENT, MODELS 16 and 22 NAME: MOBILE X-RAY SYSTEM
GE MEDICAL SYSTEMS - EUROPE MANUFACTURER: Loncin, Belgium
GE MEDICAL SYSTEMS DISTRIBUTOR: Milwaukee, Wi
INDICATIONS FOR USE:
The ACCENT systems are mobile image-intensified fluoroscopic x-ray systems, intended for use in The ACCENT systems are noble intension instruction instructions of the orgery, pacemaker
general surgical procedures such as orthopedics, traumatology, visceral surgery, pace general surgiour procedures or other interventional procedures.
DEVICE DESCRIPTION
The ACCENT system is composed of:
a mobile C-Arm that includes:
- an image intensifier with CCD video camera .
- an x-ray generator and controller ●
- an x-ray generator and comfolio.
an x-ray tube mounted in the same housing as the x-ray generator ● - a beam-limiting device ●
- optional: a Laser beam alignment device .
- optional: a dose area product meter and display .
and a monitor cart that includes:
- TV monitors ●
- r v Thonkols
an image digital processing and storage system, may be of different models . - optional: VCR and video printers ●
| Materials: | All construction and materials are compliant with UL 2601-1, and IEC 601-1 |
|---|---|
| equipment standards. | |
| Design: | The design meets or exceeds standards set forth in UL 2601-1 and IEC 601- |
- There are hardware redundancies to prevent single point failures (such as
x-ray emission and C-Arm motion) |
| Energy Source: | Single phase, plus ground, 100-108-120-200-208-220-228-240 V, 50/60
Hz.
The supply voltage is set at the installation. |
| Exposure levels: | Maximum rated peak tube potential: 110 kV
Fluoroscopic Entrance Exposure Rate (EER): less than 10 R/min.
Radiography: 160 mAs maximum, manual setting
Systems comply with the requirements of 21CFR 1020.30 - 31 - 32 |
| Mechanical features: | - mobile: forth and back, interlocked lateral travel
- C-Arm: forth and back, tilting (wig-wag), rotations |
1
MARKETING HISTORY:
The ACCENT systems perform the same functions and replace the units listed below:
STENOSCOP 2, Model 6000 ACCENT 16: STENOSCOP 2, Model 9000 ACCENT 22:
ADVERSE EFFECTS ON HEALTH:
The potential hazards (x-ray, mechanical and electrical) are controlled by compliance with the label The potential hazards (X-ray, mechanical and electived) are ochinations of other in the labeling.
federal x-ray standard, adherence to industry standards (UL 2601-1) and wari
CONCLUSIONS
The ACCENT systems are substantially equivalent to the above listed devices. The ACCENT systems are substantians of operation are very similar.
The energy source, exposure levels and principles of operation are very similar. The energy source, exposure levels and pinciples of operation in the courte.
2
Image /page/2/Picture/1 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around a central emblem. The emblem depicts a stylized image of three human profiles facing right, with flowing lines extending from their heads, resembling a bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Mr. Mike Chilbert Quality, Safety, & Regulatory Engineer Technology & Product Assurance Group GE Medical Systems P.O. Box 414, W-709 MILWAUKEE WI 53201
NOV 1 7 2011
Re: K980322
Trade/Device Name: Accent 16 and 22 (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: January 22, 1998 Received: January 27, 1998
Dear Mr. Chilbert:
This letter corrects our substantially equivalent letter of April 24, 1998.
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
3
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); 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/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/Resourcesfor You/Industry/default.htm.
Sincerely Yours,
Michael D. O'Hannon 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
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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
avice Name: __ Accent Mobile X-RAY System_
Indications For Use:
The ACCENT systems are mobile image-intensified fluoroscopic x-ray systems, intended for use in general surgical procedures such as orthopedics, traumatology, visceral surgery, pacemaker implants, urology, etc. or other interventional procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Slavid C. Segnor
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devi
510(k) Number K980322
Prescription Use_ (Per 21 CFR 801.109)
OR
ﺎ.
Over-The-Counter Use_