(17 days)
Not Found
No
The summary describes an automatic collimator with shutters and a filter, with no mention of AI, ML, image processing, or data-driven performance studies.
No.
The device is intended for diagnostic radiographic/fluoroscopic applications, which is for information gathering rather than treating a disease or condition.
Yes
The text explicitly states "The Omega R605 FACS automatic collimator is intended for use in diagnostic radiographic/fluoroscopic applications." and "The Omega R 605FACS is an automatic collimator designed for use in diagnostic".
No
The device description explicitly states it is an "automatic collimator," which is a hardware component used in radiographic/fluoroscopic systems.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "intended for use in diagnostic radiographic/fluoroscopic applications." This describes a device used for imaging the body, not for testing samples (like blood, urine, or tissue) outside the body.
- Device Description: The description details a "collimator," which is a component of an X-ray system used to shape the X-ray beam. This is consistent with an imaging device, not an IVD.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in samples.
- Providing information about a patient's health status based on sample analysis.
Therefore, the Omega R605 FACS automatic collimator is a component of a medical imaging system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Omega R605 FACS automatic collimator is intended for use in diagnostic radiographic/fluoroscopic applications.
Product codes (comma separated list FDA assigned to the subject device)
90 IZW
Device Description
The Omega R 605FACS is an automatic collimator designed for use in diagnostic Trie Offically of tool AOO is an adtomatio continues round field shutters and an additional lung filter for cardiac application.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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.
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
§ 892.1610 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.
0
OMEGA MEDICAL IMAGING, INC.
510(k) SUMMARY
JAN 3 1 2005
| Company Name: | Omega Medical Imaging, Inc |
|---|---|
| Address: | 675 Hickman Circle |
| Sanford, FL 32771 | |
| Telephone No: | 407-323-9400 |
| Registration No.: | 1052701 |
| Contact person: | James A. Princehorn |
| Date Prepared | 3 January 2005 |
| Device (trade) name: | Automatic Beam-limiting Device Model R605FACS |
| Classification name: | Diagnostic X-Ray Beam-Limiting Device (21 CFR 892.1610) |
| Class II (Procode: 90 IZW) | |
| Common/usual name: | Automatic Radiographic/fluoroscopic Collimator |
Predicate device:
- Dunlee automatic "FORMAT A" collimator manufactured by Philips Medical Systems legally . marketed under number K031597.
- marketed under number Roo roof :
Advantech Model R600/800 series collimators manufactured by RALCO S.R.L. legally marketed . under number K904182
Device description:
Device desoription:
The Omega R 605FACS is an automatic collimator designed for use in diagnostic Trie Offically of tool AOO is an adtomatio continues round field shutters and an additional lung filter for cardiac application.
Intended use:
- The Omega R605 FACS automatic collimator is intended for use in diagnostic . radiographic/fluoroscopic applications.
Safety information:
- mornation.
The Omega R605 FACS collimator will comply with the applicable requirements of 21 CFR . 1020.30, 21 CFR 1020.31, and 21 CFR 1020.32. - The Omega R605 FACS collimator will comply with the international safety standards IEC . 60601-1, IEC 60101-1-2, and IEC 60601-1-3.
- The Omega R605 FACS will comply with CE Marking requirements. .
- The Omega R605 FACS will comply with UL 60601-1 and CAN/USA C22.2 No.601.1-M90 .
Conclusion:
Oonega R605 FACS collimator does not introduce any new indications for use, nor does the use of The Omoga Rood Proo Considers the R605 FACS collimator the R605 FACS collimator to be substantially equivalent with the predicate devices.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines representing its wings or body. The bird is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 3 1 2005
Mr. James A. Princehorn President Omega Medical Imaging, Inc. 675 Hickman Circle SANFORD FL 32771
Re: K050092 Trade/Device Name: Omega R605 FACS automatic collimator Regulation Number: 21 CFR 892.1610 Regulation Name: Diagnostic x-ray Beam-limiting device Regulatory Class: II Product Code: 90 IZW Dated: January 5, 2005 Received: January 14, 2005
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 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.
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.
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 this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmadsmam.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
3
Omega Medical Imaging, Inc.
Omega R605 FACS Collimator
Indications for Use:
The Omega R605 FACS automatic collimator is intended for use in diagnostic radiographic/fluoroscopic applications.
Prescription Use
David G. Ingram