(32 days)
No
The document does not mention AI, ML, or any related terms, and the device description focuses on hardware modifications.
No
The device is intended for "taking diagnostic radiographic exposures" which is a diagnostic purpose, not a therapeutic one.
Yes
The device is described as "taking diagnostic radiographic exposures," indicating its purpose is to aid in diagnosis.
No
The device description clearly states it is a "digital radiographic system" and involves replacing a "digital radiographic detector," indicating it is a hardware system, not software only.
Based on the provided information, the X3C 2200 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for taking diagnostic radiographic exposures of various body parts. This is an in vivo diagnostic procedure, meaning it is performed on a living organism (the patient).
- Device Description: The device is described as a digital radiographic system, which is a type of medical imaging equipment used to capture images of the inside of the body.
- Input Imaging Modality: The input imaging modality is Digital Radiographic, which is an imaging technique applied directly to the patient.
IVD devices, by definition, are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside of the body) to provide information for diagnostic purposes. The X3C 2200 does not perform this function.
N/A
Intended Use / Indications for Use
The X3C 2200 is intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients can be performed with patient sitting, standing or lying in the prone or supine positions.
The X3C 2200 (510k submission device) is not intended for mammography.
Product codes
KPR, MQB
Device Description
The X3C 2200 is a modification to Xplorer 2200 where the Xplorer 1000 digital radiographic detector (a previously marketed device covered by 510k K992955) in Xplorer 2200 system is replaced with X3C digital radiographic detector, previously marketed device under K070079. The X3C 2200 system is manufactured by Imaging Dynamics.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic
Anatomical Site
skull, spinal column, chest, abdomen, extremities, and other body parts
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
qualified/trained doctor or technologist
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)
Non-clinical tests: The device has been evaluated for performance, biocompatibility and effectiveness as well as thermal, electrical and mechanical safety and has been found to substantially equivalent to predicate device. The design and development process of the manufacturer conforms to 21 CFR part 820, ISO 9001 and ISO 13485 quality systems.
Clinical tests: No clinical tests conducted.
Conclusion: The device was evaluated against the predicate device (Xplorer 2200 -K063039) for all performance, safety & effectiveness requirements and found as substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Xplorer 2200 Digital Radiographic System, (K063039)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.
0
Special 510k Submission X3C 2200 Digital Radiographic System
510k Summary
| 1. Submitter: | Imaging Dynamics Company Ltd
Suite 151, Pegasus Way NE
Calgary, AB,
Canada T2E 8M5 | | | JUN 2 2 2007 |
|---------------------------|-----------------------------------------------------------------------------------------------|--|--|--------------|
| Contact person: | Shirantha Samarappuli
Manager - Regulatory Affairs
Tel: 403 251 9939; Fax: 403 251 1771 | | | |
| Date Prepared: | May 14, 2007 | | | |
| 2. Device Name: | X3C 2200 Digital Radiographic System, | | | |
| 3. Device Classification: | Class II, 892.1680 (KPR), 892.1630 (MQB), | | | |
| 4. Predicate Device: | Xplorer 2200 Digital Radiographic System, (K063039) | | | |
-
- Device Description: The X3C 2200 is a modification to Xplorer 2200 where the Xplorer 1000 digital radiographic detector (a previously marketed device covered by 510k K992955) in Xplorer 2200 system is replaced with X3C digital radiographic detector, previously marketed device under K070079. The X3C 2200 system is manufactured by Imaging Dynamics.
-
- Indications for Use: The X3C 2200 is intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. The X3C 2200 (510k submission device) is not intended for mammography,
- Comparison with predicate device: The X3C 2200 is substantially equivalent to the currently 7. marketed Xplorer 2200. X3C 2200 device does not alter the fundamental scientific technology from Xplorer 2200 predicate device. The replacement of Xplorer 100 digital radiographic detector (K992955) with X3C digital radiographic detector (K070079) is the only significant change between the 2 devices. X3C 2200 has the same intended use as the predicate device.
- a. Non-clinical tests: The device has been evaluated for performance, biocompatibility and effectiveness as well as thermal, electrical and mechanical safety and has been found to substantially equivalent to predicate device. The design and development process of the manufacturer conforms to 21 CFR part 820, ISO 9001 and ISO 13485 quality systems.
- b. Clinical tests: No clinical tests conducted.
- C. Conclusion: The device was evaluated against the predicate device (Xplorer 2200 -K063039) for all performance, safety & effectiveness requirements and found as substantially equivalent to the predicate device.
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Image /page/1/Picture/0 description: The image shows a circular seal with text around the perimeter and a stylized graphic in the center. The text around the perimeter reads "U.S. Department of Health & Human Services". The graphic in the center consists of three curved lines that resemble a stylized human figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Ms. Shirantha Samarappuli Manager - Regulatory Affairs Imaging Dynamics Company Ltd 151, 2340 Pegasus Way NE Calgary, Alberta, T2E 8M5 CANADA
JUN 2 2 2007
Re: K071401
Trade/Device Name: X3C 2200 Digital Radiographic System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR, MQB Dated: May 18, 2007 Received: May 21, 2007
Dear Ms. Samarappuli:
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 (Premarket Approval), 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.
Image /page/1/Picture/10 description: The image shows a logo with the text "FDA Centennial 1906-2006" inside of a circle. Below the logo, the text "Protecting and Promoting Public Health" is visible. The text is written in a decorative font. The image appears to be a scan of a document.
2
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.
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 this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Special 510k Submission X3C 2200 Digital Radiographic System
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: X3C 2200 digital radiographic system
Indications for Use:
The X3C 2200 is intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients can be performed with patient sitting, standing or lying in the prone or supine positions.
The X3C 2200 (510k submission device) is not intended for mammography.
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| Nancy Shoglon | ||
| (Division Sign-Off) | ||
| Division of Reproductive, Abdominal, and Radiological Devices | ||
| 510(k) Number | K071401 | |
| Prescription Use | ||
| (Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use |
| (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)