(77 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like deep learning, neural networks, or training/test sets for algorithms. The description focuses on physical components and intended use.
No
The device is described as an "automatic beam limiting device" for X-ray diagnostic applications, which means its purpose is to control the X-ray beam during imaging, not to treat a condition or disease.
Yes
The device is explicitly stated as being intended for use in X-ray diagnostic radiographic/fluoroscopic applications and is described as a device for use in diagnostic radiographic/fluoroscopic applications.
No
The device description explicitly states it is an "automatic beam limiting device" and lists physical components like "square field shutters, spectral filters, and an additional lung filter," indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "for use in X-ray diagnostic radiographic/fluoroscopic applications." This describes a device used during an imaging procedure on a patient, not a device used to test samples outside of the body (which is what IVD devices do).
- Device Description: The description details components like "square field shutters, spectral filters, and an additional lung filter." These are all parts of an X-ray imaging system used to shape and filter the X-ray beam directed at a patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other elements typically associated with in vitro diagnostics.
In summary, the Omega R650 QDASM is a component of an X-ray imaging system used for diagnostic imaging of patients, not for testing samples in a laboratory setting.
N/A
Intended Use / Indications for Use
The Omega R650 QDASM automatic beam limiting device is intended for use in X-ray diagnostic radiographic/fluoroscopic applications.
Product codes
90 IZW
Device Description
The Omega R 650 QDASM is an automatic beam limiting device designed for use in diagnostic radiographic/fluoroscopic applications. It includes square field shutters, spectral filters, and an additional lung filter for cardiac application. This device is substantially equivalent to the predicate devices with respect to technological characteristics.
Mentions image processing
Not Found
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1610 Diagnostic x-ray beam-limiting device.
(a)
Identification. A diagnostic x-ray beam-limiting device is a device such as a collimator, a cone, or an aperture intended to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray beam.(b)
Classification. Class II (special controls). The 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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OMEGA MEDICAL IMAGING, INC.
510(k) SUMMARY
KO93572
| Company Name: | Omega Medical Imaging, Inc | FEB - 3 2010 |
|---|---|---|
| Address: | 675 Hickman Circle | |
| Sanford, FL 32771 | ||
| Telephone No: | 407-323-9400 | |
| Registration No.: | 1052701 | |
| Contact person: | James A. Princehorn | |
| Date Prepared: | 16 November 2009 | |
| Device (trade) name: | Automatic Beam-limiting Device Model R650 QDASM | |
| Common/usual name: | Automatic Radiographic/fluoroscopic Collimator | |
| Classification name: | Diagnostic X-Ray Beam-Limiting Device (21 CFR 892.1610) | |
| Class II (Procode: 90 IZW) |
Predicate device:
- Dunlee automatic "FORMAT A" collimator manufactured by Philips Medical Systems legally . marketed under number K031597.
- Omega Model R605 FACS collimators manufactured by RALCO S.R.L legally marketed under � number K050092
Device description:
The Omega R 650 QDASM is an automatic beam limiting device designed for use in diagnostic radiographic/fluoroscopic applications. It includes square field shutters, spectral filters, and an additional lung filter for cardiac application. This device is substantially equivalent to the predicate devices with respect to technological characteristics.
Intended use:
- The Omega R650 QDASM automatic beam limiting device is intended for use in diagnostic . radiographic/fluoroscopic applications.
Safety information:
- The Omega R650 QDASM collimator will comply with the applicable requirements of 21 CFR � 1020.30, 21 CFR 1020.31, and 21 CFR 1020.32.
- The Omega R650 QDASM collimator will comply with the international safety standards IEC . 60601-1, IEC 60101-1-2, and IEC 60601-1-3.
- The Omega R650 QDASM will comply with CE Marking requirements. .
- The Omega R650 QDASM will comply with UL 60601-1 and CAN/USA C22.2 No.601.1-M90 .
Conclusion:
The Omega R650 QDASM collimator does not introduce any new indications for use, nor does the use of the device result in any new potential hazard. Omega considers the R650 QDASM collimator to be substantially equivalent with the predicate devices.
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Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a bird-like figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
FEB - 3 2010
Mr. James A. Princehorn President Omega Medical Imaging, Inc. Cardiac and Vascular Imaging Systems 675 Hickman Circle SANFORD FL 32771
Re: K093572
Trade/Device Name: R650 QDASM Beam Limiting Device Regulation Number: 21 CFR 892.1610 Regulation Name: Diagnostic x-ray beam-limiting device Regulatory Class: II Product Code: IZW Dated: November 16, 2009 Received: November 18, 2009
Dear Mr. Princehorn:
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 Found, Or vo 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 provisiopp of the I 1 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 (reportion 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.
Donald J. Trump
St.Pierre Donald J. 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 Form
510(k) Number (if known): K093572
Device Name: R650 QDASM Beam Limiting Device
Indications for Use:
The Omega R650 QDASM automatic beam limiting device is intended for use in X-ray diagnostic radiographic/fluoroscopic applications.
Prescription Use Prescription Ose
(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 OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K093572
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