(73 days)
Not Found
No
The summary mentions image processing but does not explicitly mention AI, ML, or related terms like deep learning, nor does it describe any training or test sets typically associated with AI/ML development.
No.
The device is used for fluoroscopic examination and image diagnosis, which are diagnostic purposes, not therapeutic.
Yes
The device description states that the 3Dscope acquires, processes, displays, and stores x-ray images "for image diagnosis," indicating its use in diagnosing medical conditions.
No
The device description explicitly states it is a "mobile fluoroscopic system" and "acquires, processes, displays, and stores x-ray images," indicating it includes hardware components for image acquisition (x-ray) and display, in addition to software for processing and storage.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "fluoroscopic examination of a patient." This involves imaging the inside of the body using X-rays, which is an in-vivo (within the living body) procedure.
- Device Description: The description clearly states it's a "mobile fluoroscopic system" that "acquires, processes, displays, and stores x-ray images." This is consistent with medical imaging equipment used on a patient.
- Input Imaging Modality: The input is "x-ray," which is a form of radiation used for imaging the body, not for analyzing samples outside the body.
IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device operates directly on the patient.
N/A
Intended Use / Indications for Use
The 3Dscope is a mobile apparatus used for fluoroscopic examination of a patient.
Product codes (comma separated list FDA assigned to the subject device)
90 JAA
Device Description
The 3Dscope is a compact, mobile fluoroscopic system designed for general fluoroscopic imaging. The 3Dscope acquires, processes, displays, and stores x-ray images, for image diagnosis.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
Not Found
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)
Not Found
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.
Digiscope RX-2 (9" option) K965013
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
12041213
JUL 2 2 2004 SECTION 6 - 510(k) SUMMARY
[Submitted pursuant to 21 CFR 807.87(h)]
1. Submitter Information
| Submitter. | Direx Systems Corporation
11 Mercer Road
Natick Business Park
Natick, MA 01760 |
|--------------------------------------|-----------------------------------------------------------------------------------------|
| Telephone:
Fax:
Contact Person | (508) 651-0900
(508) 651-8125
Larisa Gershtein
QA Manager |
| Contact Person e-mail address: | lgershtein@direxusa.com |
| 2. Device | |
| Trade/Proprietary Name: | 3Dscope. |
| Classification Name: | System, x-ray, fluoroscopic, image-
intensified. |
| Classification Name/ Product code: | 90 JAA |
| Regulatory Class: | Class II |
| Regulation Number: | 21 CFR 892.1650 |
3. Predicate Device
Digiscope RX-2 (9" option) K965013
4. Intended Use
The 3Dscope is a mobile apparatus used for fluoroscopic examination of a patient.
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5. Device Description
The 3Dscope is a compact, mobile fluoroscopic system designed for general fluoroscopic imaging. The 3Dscope acquires, processes, displays, and stores x-ray images, for image diagnosis.
6. Performance Testing
The 3Dscope conforms to the following standards: IEC 60601-1 (1998) + A1(1991) + A2(1995) IEC 60601-1-1 (2000) IEC 60601-1-2 (2001) IEC 60601-1-3 (1994) IEC 60601-2-7 (1998) IEC 60601-1-4 (2000) ISO 14971 (2000) FDA CDRH 21CFR 1020.30 FDA CDRH 21CFR 1020.32
7. Conclusion
The 3Dscope meets the requirements for a special 510(k) by the virtue of being a minor modification, which does not change the intended use, fundamental technology or reduce safety and effectiveness, of the Company's predicate device, the Digiscope RX-2 (9" option).
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized graphic. The graphic is a blue-colored emblem that resembles a bird or a stylized human figure with outstretched arms. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Larisa Gershtein QA Manager DiREX Systems Corporation 11 Mercer Road MATICK MA 01760
AUG 2 3 2013
Re: K041213
Trade/Device Name: 3Dscope Regulation Number: 21 CFR 892.1650 2 3 2011 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OXO Dated: June 22, 2004 Received: June 24, 2004
Dear Ms. Gershtein:
This letter corrects our substantially equivalent letter of July 22, 2004.
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21. Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809): medical device reporting of
3
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting 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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Image /page/4/Picture/0 description: The image shows the logo for Direx Systems Corp. The logo is in black and white, with the word "Direx" in large, bold letters. Below the word "Direx" is a horizontal line, and below that is the text "SYSTEMS CORP." in smaller letters. The logo is simple and professional.
Attachment 4-1
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):_KO41213
Device Name:
3Dscope
Indications for Use:
The 3Dscope is a mobile apparatus used for fluoroscopic examination of a patient.
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
510(k) Number $\qquad$ \checkmark K041213
Prescription Use (Per 21 CFR § 801.109)
OR
Over the Counter Use_
Daniel A. Ingram
(Division Sign-Off) Division of Reproductive and Radiological Device 510(k) Number
11 Mercer Road ♦ Natick, Ma 01760 Phone: 1-888-TRIPTER ● Fax: 508-651-8125 c mail:promo@direxusa.com