SERIES 6600 DIGITAL MOBILE C-ARM
Device Facts
| Record ID | K951765 |
|---|---|
| Device Name | SERIES 6600 DIGITAL MOBILE C-ARM |
| Applicant | Ge Dec Medical Systems |
| Product Code | OXO · Radiology |
| Decision Date | May 11, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1650 |
| Device Class | Class 2 |
Device Story
The Series 6600 Digital Mobile C-arm is a mobile fluoroscopic imaging system used to provide real-time X-ray visualization during clinical procedures. It captures X-ray signals, processes them into digital images, and displays them for the clinician. The device is intended for use in clinical environments to assist healthcare providers in diagnostic or interventional procedures by providing immediate visual feedback. The output allows the physician to monitor anatomy and instrument placement in real-time, facilitating clinical decision-making and potentially improving procedural accuracy and patient outcomes.
Clinical Evidence
No clinical data provided; substantial equivalence is based on functional specifications and comparison to predicate devices.
Technological Characteristics
Mobile fluoroscopic X-ray system (21 CFR 892.1650). Features a C-arm form factor for positioning. Operates as an image-intensified fluoroscopic system. Technical specifications and functional characteristics are compared to predicate mobile digital imaging systems.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- OEC Medical Systems, Inc. - Series 9600 Mobile Digital Imaging System
- FluoroScan Imaging Systems, Inc. - FluoroScan Mini C-arm
- XiTec Incorporated - XiScan Mini C-arm
Submission Summary (Full Text)
{1}
K951765
MAY 11 1995
OEC
OEC MEDICAL
SYSTEMS, INC
384 WRIGHT
100 OTHERS DRIVE
Salt Lake City
UT 84116
801 328-9300
FAX 801 328-4300
### 510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
Date: April 11, 1995
Name of Submitter: OEC Medical Systems, Inc.
384 Wright Brothers Drive
Salt Lake City, UT 84116
801-328-9300
Corresponding Official: Ted L. Parrot,
Vice President, Quality/Regulatory Affairs.
Device Proprietary Name: Series 6600 Digital Mobile C-arm
Classification Name: System, X-ray, Fluoroscopic, Image-Intensified
Common/Usual Name: Fluoroscopic Imaging System
Substantial Equivalence: The Series 6600 Digital Mobile C-arm is substantially equivalent to the following systems which are currently marketed:
1) OEC Medical Systems, Inc. - Series 9600 Mobile Digital Imaging System
2) FluoroScan Imaging Systems, Inc. - FluoroScan Mini C-arm
3) XiTec Incorporated - XiScan Mini C-arm
Similarities and Differences: Refer to the attached Specification Comparison (Similarities/Differences). This chart compares the functional characteristics of the Series 6600 Digital Mobile C-arm with similar devices which are currently marketed.
)
Page 1 of 3
{2}
[LOGO]
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Mr. Ted L. Parrot
Vice President, Quality Assurance/
Regulatory Affairs and Official Correspondent
OEC Medical Systems, Inc.
384 Wright Brothers Drive
SALT LAKE CITY UT 84116
NOV 21 2011
Re: K951765
Trade/Device Name: Series 6600 Digital Mobile C-Arm
Regulation Number: 21 CFR 892.1650
Regulation Name: Image-intensified Fluoroscopic x-ray system, mobile
Regulatory Class: II
Product Code: OXO
Dated: March 14 & April 11, 1995
Received: April 17 & 21, 1995
Dear Mr. Parrot:
This letter corrects our substantially equivalent letter of May 11, 1995.
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.
{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); 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/ResourcesforYou/Industry/default.htm.
Sincerely Yours,
Mary S. Pastel
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
{4}
Dear Mobile Fluoroscopic Device Manufacture:
This letter is to advise you that the FDA is in the process of updating the Product Codes for Mobile Fluoroscopic (OXO) devices to provide greater specificity regarding Mobile X-Ray devices. Product Codes, and their definitions, can be found in our classification database (http"//www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm).
Mobile X-Ray devices have expanded greatly in scope since the creation of the first Mobile X-Ray devices product code, IZL, over 30 years ago: from standard mobile radiographic systems to sophisticated mobile interventional fluoroscopy devices. Because of the variety of mobile X-Ray devices currently on the market, the new product code will allow FDA to distinguish between the different types of mobile S-Ray devices marketed in the United States (U.S.), thereby allowing us to serve the Medical Imaging device industry and other stakeholders in a more clear and efficient manner.
# **What you should do at this time:**
When preparing import paperwork, including your FDA Listing, **you must** continue to reference the "Current Product Codes" that are found on your 510(k) letter of substantial equivalence to avoid delays at the port of entry into the U.S. Do **not** use the "Planned Common Name and Planned Product Code" on any FDA Submission until the codes have been finalized for your device, and you have been **notified by FDA by receipt of a revised letter of substantial equivalence for your 510(k)(s). (Attached)**
# **Need Further Clarifications?**
If you need further clarification on the issue or any other type of assistance in complying with FDA regulations, please contact the Division of Small Manufactures, International and Consumer Assistance, (DSMICA), by email at DSMICA@CDRH.FDA.GOV
John Stigi
Director
Division of Small Manufactures, International and Consumer Assistance
Office of Communication, Education and Radiation Programs
Center for Devices and Radiological Health
U.S. Food and Drug Administration
