(193 days)
K963037, K911454A
Not Found
No
The description focuses on standard digital image processing techniques (brightness, contrast, edge enhancement, zoom, subtraction) and does not mention any AI/ML algorithms or capabilities.
No.
The device is an imaging system designed for digital videography and image processing, not for treating diseases or conditions.
Yes
Explanation: The device is described as an imaging system that allows operators to view and enhance images to "bring out diagnostic details." This explicitly states its role in aiding diagnosis by improving the visibility of features relevant to medical conditions.
No
The device description explicitly lists hardware components such as a fluoroscopic TV camera, monitors, and an image processor, indicating it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The InfiMed Orion Fluoroscopic imaging system is described as a digital imaging system that replaces conventional film techniques in fluoroscopy, interventional fluoroscopy, angiography, and cardiac imaging procedures. It works by capturing and processing images generated by X-rays passing through the patient's body.
- Lack of Specimen Analysis: The description does not mention the analysis of any biological specimens. The system directly images the internal structures of the patient using X-rays.
Therefore, the InfiMed Orion Fluoroscopic imaging system falls under the category of medical imaging devices used for diagnostic purposes in vivo (within the living body), not in vitro (in glass or outside the body).
N/A
Intended Use / Indications for Use
The InfiMed Orion Fluoroscopic imaging system is a high resolution, digital imaging system designed for digital videography. It is intended to replace conventional film techniques in multipurpose or dedicated applications where general fluoroscopy, interventional fluoroscopy or angiography or cardiac imaging procedures are performed.
The Orion system allows the operator to view and enhance 1000 line fluoroscopy. High resolution digital spot images ( 1024x1024)) may be acquired at single or rapid acquisition rates. Images may be viewed and enhanced enabling the operator to bring out diagnostic details difficult or impossible to see using conventional imaging techniques.
The Orion system enables the operator to hardcopy image with a laser printer or send images over a network. The major system components include: a fluoroscopic TV camera, monitors, and an image processor.
Product codes (comma separated list FDA assigned to the subject device)
OWB and JAA
Device Description
The Orion fluoroscopic imaging system allows the use of digital imaging to conventional X-ray system used in the general fluoroscopy, interventional fluoroscopy, angiography and cardiac imaging arcas. The system works by installing a CCD camera on the output of the image intensifier and digitizing the video output of the image intensifier. The digital image can then be displayed on the monitor, it can be stored to disk, or sent to an external device such as a laser imager or a DICOM network. The image can also be processed, including brightness and contrast, edge enhancement, zoom, and subtraction.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopic 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.
K963037, K911454A
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.
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FEB 1 2 2002
510(k) Summary of Safety and Effectiveness
Date Prepared: June 30, 2001 Name of Contact Person: Ralph J. Flatau Address: InfiMed, Inc 121 Metropolitan Drive Liverpool NY 13088 Phone: (315)453-4545 x224 Fax: (315)453-4550
Device trade name: Orion Fluoroscopic Imaging System Common name: Digital Radiography System Classification Name: Image intensified fluoroscopic X-ray system
Device Description:
The Orion fluoroscopic imaging system allows the use of digital imaging to conventional X-ray system used in the general fluoroscopy, interventional fluoroscopy, angiography and cardiac imaging arcas. The system works by installing a CCD camera on the output of the image intensifier and digitizing the video output of the image intensifier. The digital image can then be displayed on the monitor, it can be stored to disk, or sent to an external device such as a laser imager or a DICOM network. The image can also be processed, including brightness and contrast, edge enhancement, zoom, and subtraction.
Intended Use:
The InfiMed Orion Fluoroscopic imaging system is a high resolution, digital imaging system designed for digital videography. It is intended to replace conventional film techniques in multipurpose or dedicated applications where general fluoroscopy, interventional fluoroscopy or angiography or cardiac imaging procedures are performed.
The Orion system allows the operator to view and enhance 1000 line fluoroscopy. High resolution digital spot images ( 1024x1024)) may be acquired at single or rapid acquisition rates. Images may be viewed and enhanced enabling the operator to bring out diagnostic details difficult or impossible to see using conventional imaging techniques.
The Orion system enables the operator to hardcopy image with a laser printer or send images over a network. The major system components include: a fluoroscopic TV camera, monitors, and an image processor.
Conclusions drawn from comparison:
The Orion fluoroscopic imaging system can be considered to be substantially equivalent to the InfiMed GoldOne Fluoroscopic System ( 510(k)-K963037) and the InfiMed FC2000 Fluoroscopic System ( 510(k) - K911454A). Virtually all of the features offered by either of the predicate devices are offered by the Orion product. There are a number of additional features that the Orion product offers, most of which are possible because of the increased power of the system. Some of these features require additional interfaces to acquire the data. In addition, to facilitate patient safety, some key interfaces have been changed from wires to fiber optics.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Brian N. Killoran Quality Assurance Manager InfiMed, Inc. 121 Metropolitan Drive LIVERPOOL NY 13088
MAY - 7 2012
Re: K012490
Trade/Device Name: Orion Digital Imaging System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB and JAA Dated: December 12, 2001 Received: December 21, 2001
Dear Mr. Killoran:
This letter corrects our substantially equivalent letter of February 12, 2002.
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.
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 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 (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) 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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Indications for Use Statement
KO12490 510(k) Number
Unknown at this time.
Device Name
Orion Fluoroscopic Imaging System.
Indications for Use
The InfiMed Orion Fluoroscopic imaging system is a high resolution, digital imaging system designed for I wo mained on by . It is intended to replace conventional film techniques in multipurpose or dedicated applications where general fluoroscopy, interventional fluoroscopy or angiography or cardiac imaging procedures are performed.
The Orion system allows the operator to view and enhance 1000 line fluoroscopy. High resolution digital spot images ( 1024x1024) may be acquired at single or rapid acquisition rates. Images may be viewed and enhanced enabling the operator to bring out diagnostic details difficult or impossible to see using conventional imaging techniques. Images can be stored locally for medium term storage.
The Orion system enables the operator to hardcopy image with a laser printer or send images over a network for longer term storage. The major system components include: a fluoroscopic TV camera, monitors, and an image processor.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (DOE)
| Prescription Use | / | Or | Over the counter Use | |
|---|---|---|---|---|
| Per 21 CFR 801.109 | (Optional format 1-2-96) |
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, | |
| and Radiological Devices | |
| 510(k) Number | K012490 |
\INFNT2\PROJECTS\OrionVascular\Regulatory\510K\510k_FDA.doc
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