(44 days)
Not Found
No
The summary does not mention AI, ML, deep learning, or any related terms. The described functions are standard for imaging systems.
No
This device is for diagnostic imaging, not for treatment.
Yes.
Explanation: The device is an imaging system used for fluoroscopic imaging of patient extremities, which is a method of diagnosing medical conditions.
No
The device description explicitly states it is a "compact, mobile, mini C-arm system," which is a hardware device used for fluoroscopic imaging. While it includes software for image manipulation and control, it is not solely software.
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 (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The XiScan 4000 is an imaging system that uses fluoroscopy to create images of patient extremities directly on the patient's body. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states "fluoroscopic imaging of patient extremities," which is an in-vivo (within the living body) imaging procedure, not an in-vitro (in glass/outside the body) diagnostic test.
N/A
Intended Use / Indications for Use
The XiScan 4000 Transportable Imaging System is intended for fluoroscopic imaging of patient extremities.
Product codes (comma separated list FDA assigned to the subject device)
90 JAA
Device Description
The XiScan 4000 Transportable Imaging System is a compact, mobile, mini C-arm system specifically designed for fluoroscopic imaging of patient extremities. The XiScan 4000 Imaging System can be operated in either manual or automatic exposure rate control (AERC) modes, with options of reduced radiation LOW DOSE and high resolution STANDARD DOSE when using AERC. The XiScan 4000 offers a range of functions for image manipulations. It features touchscreen controls to manage on-screen patient information and image storage.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopic
Anatomical Site
patient extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
A bench test comparison of the devices confirmed that the patient X-ray exposure rates for imaging various anatomies are similar.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
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
NOV 1 2 2003
04301 510(k) Summary for
XiScan 4000 Imaging System
1. SPONSOR
XiTec Holdings LLC 4 New Park Road East Windsor, CT 06088
Contact Person: Mr. Steven Hanright 860-292-7055 Telephone:
September 26, 2003 Date Prepared:
DEVICE NAME 2.
Proprietary Name: XiScan 4000 Transportable Imaging System Common/Usual Name: Fluoroscopic mini C-arm systems Image-intensified fluoroscopic X-ray system Classification Name:
PREDICATE DEVICE 3.
XiScan 6000 Imaging System (K003568)
INTENDED USE 4.
The XiScan 4000 Transportable Imaging System is intended for fluoroscopic imaging of patient extremities.
న. DEVICE DESCRIPTION
The XiScan 4000 Transportable Imaging System is a compact, mobile, mini C-arm system specifically designed for fluoroscopic imaging of patient extremities. The XiScan 4000 Imaging System can be operated in either manual or automatic exposure rate control (AERC) modes, with options of reduced radiation LOW DOSE and high resolution STANDARD DOSE when using AERC. The XiScan 4000 offers a range of functions for image manipulations. It features touchscreen controls to manage on-screen patient information and image storage.
1
5033966
BASIS FOR SUBSTANTIAL EQUIVALENCE 6.
The XiScan 4000 Transportable Imaging System has the same intended use, and similar technical specifications, as compared to the predicate device. Both devices are mobile mini C-arm systems with similar technique factors, SIDs, field-of-view sizes, and image enhancement options. A bench test comparison of the devices confirmed that the patient X-ray exposure rates for imaging various anatomies are similar. Based on these comparisons, the XiScan 4000 Transportable Imaging System is substantially equivalent to the XiScan 6000 Imaging System.
2
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 three curved lines representing its body and wings. The eagle is positioned to the right of the text, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 2 2003
Xitec Holding, LLC % Mr. Daniel J. Dillion, RAC Staff Consultant Medical Device Consultants, Inc. 49 Plain Street NORTH ATTLEBORO MA 02760 Re: K033066 Trade/Device Name: XiScan 4000 Transportable Imaging System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: 90 JAA Dated: October 22, 2003 Received: October 23, 2003
Dear Mr. Dillion:
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, listing 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.
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.
3
Page 2
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of 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 the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K023066 510(k) Number (if known):
Device Name: __ XiScan 4000 Transportable Imaging System
Indications For Use:
The XiScan 4000 Transportable Imaging System is intended for fluoroscopic imaging of patient extremities.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Brogdon
(Division Sign-Off)
Abdom Division of Reproductive. and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
Prescription Use
(Per 21 CFR 801.109)
ાર
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
XiTec Holdings LLC 510(k) XiScan 4000 Imaging System September 26, 2003
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