LHO
8 FDA 510(k) clearances · Product code
103 daysmedian time to decision
240 days90th percentile
8clearances measured
FDA profile
- Official device name
- Instrument, Quality-Assurance, Radiologic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 892.1940
- Medical specialty
- Radiology
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 2003: 3
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEM (K042733) | Standard Imaging, Inc. | 2004-11-15 |
| ULTIMETER (K873956) | Radiation Measurements, Inc. | 1987-10-30 |
| MULTI PURPOSE MODEL 76-903 (K860260) | Victoreen, Inc. | 1986-05-07 |
| MAGNETIC RESONANCE IMAGING UNIFORMITY/T1 76-901 (K853754) | Victoreen, Inc. | 1986-05-07 |
| MRI SLICE THICKNESS & CONTIGUITY PHANTOM #76-902 (K860100) | Victoreen, Inc. | 1986-04-22 |
| BDS-3 BEAM DATA SCANNER (K844620) | Varian Assoc., Inc. | 1985-07-01 |
| RFA-7 RADIATION FIELD ANALYZER (K845007) | Varian Assoc., Inc. | 1985-07-01 |
| DIGI-X (K834483) | Radiation Measurements, Inc. | 1984-03-05 |
Track LHO automatically
Every clearance here is in the API, with alerts when new ones post.