(126 days)
The Soyee Portable X-Ray Unit Model SY-HF-110 is intended for portable and mobile general purpose diagnostic radiography in the field and clinic applications.
Not Found
This document is a 510(k) clearance letter for the Soyee Portable X-Ray Unit Model SY-HF-110, indicating substantial equivalence to a legally marketed predicate device.
Therefore, the letter does not contain details about specific acceptance criteria, device performance metrics, or a study that proves the device meets such criteria. Instead, the 510(k) process relies on demonstrating that the new device is as safe and effective as an already cleared predicate device, rather than requiring new clinical studies to establish performance against specific, pre-defined acceptance criteria for the new device itself.
The document states:
- Trade/Device Name: Soyee Portable X-Ray Unit Model SY-HF-110
- Regulation Number: 21 CFR 892.1720
- Regulation Name: Mobile x-ray system
- Regulatory Class: II
- Product Code: IZL
- Indications for Use: Portable and mobile general purpose diagnostic radiography in the field and clinic applications.
To answer your request, information on acceptance criteria and a study proving device performance would typically be found in the 510(k) submission document itself (which is not provided here), where the comparison to the predicate device is detailed. The provided letter is the FDA's decision based on that submission.
Without the actual 510(k) submission, it's impossible to fill in the requested table and details about the study.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JUL 1 1 2007
Sovee Products, Inc. % Mr. Stephen T. Mlcoch President North American Technical Services (NATS) Corp. 30 Northport Road SOUTH BEACH NY 11789
Re: K070634
Trade/Device Name: Soyee Portable X-Ray Unit Model SY-HF-110 Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL Dated: May 25, 2007 Received: June 6, 2007
Dear Mr. Mlcoch:
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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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 yours,
Nancy C Hodgdon
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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Soyee Portable X-Ray Unit Model SY-HF-110 510K Notification
INDICATIONS FOR USE
510{k) Number (if known):
Soyee Portable X-Ray Unit Model SY-HF-110 Device Name: The Soyee Portable X-Ray Unit Model SY-HF-110 is intended for Indications for Use: portable and mobile general purpose diagnostic radiography in the field and clinic applications.
Prescription Use X (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Nancy C Brogdon
Division Sign-Division of Reproductive, Abdominal, and Radiological Devices 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.