Instrument, Quality-Assurance, Radiologic
A radiologic quality-assurance instrument is a device used to calibrate and verify the performance and accuracy of radiological imaging and therapy equipment, ensuring that radiation output and imaging quality meet established standards for patient safety and diagnostic reliability. The device is FDA Class 1, the lowest risk category, requiring only general controls and exempt from premarket notification. It carries product code LHO and is regulated under 21 CFR 892.1940 within the Radiology specialty. This device is exempt from Good Manufacturing Practice (GMP) regulations.
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Basic Information
- Product Code
- LHO
- Device Class
- FDA class 1
- Regulation Number
- 892.1940
- Medical Specialty
- Radiology
- Review Panel
- RA
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K042733 | STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEM | Nov 15, 2004 | Substantially Equivalent | Standard Imaging, Inc. |
| K873956 | ULTIMETER | Oct 30, 1987 | Substantially Equivalent | Radiation Measurements, Inc. |
| K860260 | MULTI PURPOSE MODEL 76-903 | May 07, 1986 | Substantially Equivalent | Victoreen, Inc. |
| K853754 | MAGNETIC RESONANCE IMAGING UNIFORMITY/T1 76-901 | May 07, 1986 | Substantially Equivalent | Victoreen, Inc. |
| K860100 | MRI SLICE THICKNESS & CONTIGUITY PHANTOM #76-902 | Apr 22, 1986 | Substantially Equivalent | Victoreen, Inc. |
| K845007 | RFA-7 RADIATION FIELD ANALYZER | Jul 01, 1985 | Substantially Equivalent | Varian Assoc., Inc. |
| K844620 | BDS-3 BEAM DATA SCANNER | Jul 01, 1985 | Substantially Equivalent | Varian Assoc., Inc. |
| K834483 | DIGI-X | Mar 05, 1984 | Substantially Equivalent | Radiation Measurements, Inc. |
FEI Numbers
This FDA classification entry is associated with 60 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 60 registration numbers. Click on an entry to view related FDA registrations.