LogoFDA 510(k) Search
K Number
K973833
Device Name
CONTROL, X-RAY DIAGNOSTIC, GENERATOR, HIGH VOLTAGE, ASSEMBLY, TUBE HOUSING DIAGNOSTIC, BEAM LIMITING DEVICE, MANUAL
Manufacturer
DYNARAD CORP.
Date Cleared
1997-12-30

(84 days)

Product Code
IZL
Regulation Number
892.1720
Type
Traditional
Panel
RA
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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 Description

NEO Mobile X-Ray System

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Dynarad Corporation's "NEO Mobile X-Ray System." It is a regulatory document from the FDA establishing substantial equivalence, not a study evaluating the device's performance against specific acceptance criteria.

Therefore, the input does not contain the information requested to fill out the table regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

The document indicates:

  • Device Name: NEO Mobile X-Ray System
  • Intended Use: General Purpose Mobile X-Ray System specifically optimized to operate within the Neo Natal environment.
  • Regulatory Class: II

Without a performance study, it's impossible to provide the requested details.

§ 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.