CONTROL, X-RAY DIAGNOSTIC, GENERATOR, HIGH VOLTAGE, ASSEMBLY, TUBE HOUSING DIAGNOSTIC, BEAM LIMITING DEVICE, MANUAL

K973833 · Dynarad Corp. · IZL · Dec 30, 1997 · Radiology

Device Facts

• Record ID: K973833
• Device Name: CONTROL, X-RAY DIAGNOSTIC, GENERATOR, HIGH VOLTAGE, ASSEMBLY, TUBE HOUSING DIAGNOSTIC, BEAM LIMITING DEVICE, MANUAL
• Applicant: Dynarad Corp.
• Product Code: IZL · Radiology
• Decision Date: Dec 30, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1720
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The DynaRad NEO is a General Purpose Mobile X-Ray System that is specifically optimized to operate within the Neo Natal environment. The maximum output is 70 kVp at 50 mA from a 115/220 V outlet

Device Story

DynaRad NEO is a mobile X-ray system designed for neonatal clinical environments. Device operates via standard 115/220V electrical outlets. System generates X-ray output with maximum capacity of 70 kVp at 50 mA. Operated by healthcare professionals (radiology technicians/clinicians) to capture diagnostic images of neonates. Output provides radiographic visualization for clinical assessment and diagnostic decision-making in neonatal care settings.

Clinical Evidence

No clinical data provided; device cleared via 510(k) substantial equivalence pathway.

Technological Characteristics

Mobile X-ray system; 70 kVp/50 mA output; 115/220V power source; optimized for neonatal environment.

Indications for Use

Indicated for general purpose mobile X-ray imaging, specifically optimized for use in neonatal environments.

Regulatory Classification

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## DEC 3 0 1997

Raymond Manez Director, Q.A./Regulatory Affairs Dynarad Corporation 19 Jefryn Blvd. West Deer Park, NY 11729

Re: K973833

NEO Mobile X-Ray System Dated: September 24, 1997 Received: October 7, 1997 Regulatory class: II 21 CFR 892.1720/Procode: 90 IZL

Dear Mr. Manez:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 (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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marked 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours

h)liau Yu
Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number (if known): KG73833

Device Name: NED

Indications For Use:

The DynaRad NEO is a General Purpose Mobile X-Ray System that is specifically optimized to operate within the Neo Natal environment. The maximum output is 70 kVp at 50 mA from a 115/220 V outlet

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Concurrence of CDRH, Office of Device Evaluation (ODE)

William Yin

(Division Sign-Off) Division of Reproductive, Abdommal, ENT, and Radiological Devices 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

..

(Optional Format 1-2-96)