(68 days)
The Model SR-115 Portable X-Ray System is intended for General Purpose Portable Radiographic Applications.
Not Found
I am sorry, but the provided text does not contain the detailed information about the acceptance criteria, device performance, or the specific study details that you requested. The document is a 510(k) clearance letter from the FDA for an "RC-115 Optional Remote Control (accessory to SR-115 Portable X-ray System)". It states that the device is substantially equivalent to legally marketed predicate devices.
The letter explicitly focuses on:
- Approval of marketing: It grants permission to market the device based on substantial equivalence.
- Regulatory classification: It identifies the device as Class II with product code IZL and regulation number 21 CFR 892.1720 (Mobile x-ray system).
- General regulatory requirements: It reminds the applicant about various FDA regulations they must comply with (registration, listing, labeling, good manufacturing practice, electronic product radiation control).
- Indications for Use: The portable X-ray system is intended for "General Purpose Portable Radiographic Applications."
It does not provide:
- A table of acceptance criteria or reported device performance.
- Details about specific studies, sample sizes, data provenance, or ground truth establishment.
- Information on expert reconciliation, MRMC studies, or standalone algorithm performance.
Therefore, I cannot fulfill your request for these specifics based on the input provided.
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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
OCT 3 1 2006
Mr. Ray Menez Director, Operations Source-Ray, Inc. 167 Keyland Court BOHEMIA NY 11716
Re: K062472
Trade/Device Name: RC-115 Optional Remote Control (accessory to SR-115 Portable X-ray System Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL Dated: August 22, 2006 Received: August 31, 2006
Dear Mr. Menez:
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.
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Protecting and Promoting Public Health
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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/cdrl/industry/support/index.html.
Sincerely vours.
Nancy Cbrogdon
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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Ver/ 3 - 4/24/96
Applicant: Source-Ray, Inc.
510(k) Number (if known):
Device Name: X-Ray System, Portable
Indications For Use: The Model SR-115 Portable X-Ray System is intended for General Purpose Portable Radiographic Applications.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Per 21 CFR 801.109)
(Optional Format 1-2
Prescription Use
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices K062472
510(k) Number
§ 892.1720 Mobile x-ray system.
(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.