LHO · Instrument, Quality-Assurance, Radiologic
Radiology · 21 CFR 892.1940 · Class 1
Overview
| Product Code | LHO |
|---|---|
| Device Name | Instrument, Quality-Assurance, Radiologic |
| Regulation | 21 CFR 892.1940 |
| Device Class | Class 1 |
| Review Panel | Radiology |
| GMP Exempt | Yes |
Identification
A radiologic quality assurance instrument is a device intended for medical purposes to measure a physical characteristic associated with another radiologic device.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 892.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K042733 | STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEM | Standard Imaging, Inc. | Nov 15, 2004 | SESE |
| K873956 | ULTIMETER | Radiation Measurements, Inc. | Oct 30, 1987 | SESE |
| K860260 | MULTI PURPOSE MODEL 76-903 | Victoreen, Inc. | May 7, 1986 | SESE |
| K853754 | MAGNETIC RESONANCE IMAGING UNIFORMITY/T1 76-901 | Victoreen, Inc. | May 7, 1986 | SESE |
| K860100 | MRI SLICE THICKNESS & CONTIGUITY PHANTOM #76-902 | Victoreen, Inc. | Apr 22, 1986 | SESE |
| K845007 | RFA-7 RADIATION FIELD ANALYZER | Varian Assoc., Inc. | Jul 1, 1985 | SESE |
| K844620 | BDS-3 BEAM DATA SCANNER | Varian Assoc., Inc. | Jul 1, 1985 | SESE |
| K834483 | DIGI-X | Radiation Measurements, Inc. | Mar 5, 1984 | SESE |
Top Applicants
- Victoreen, Inc. — 3 clearances
- Varian Assoc., Inc. — 2 clearances
- Radiation Measurements, Inc. — 2 clearances
- Standard Imaging, Inc. — 1 clearance
