FDA product code LHO: Instrument, Quality-Assurance, Radiologic
LHO is the FDA product code for instrument, quality-assurance, radiologic. It is a Class I device, regulated under 21 CFR 892.1940 and reviewed by the Radiology panel. FDA has cleared 8 510(k) submissions under LHO, from 4 different applicants. The average 510(k) review took 127 days (median 102). FDA has posted 2 recalls for LHO devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Instrument, Quality-Assurance, Radiologic |
| Device class | Class I |
| Regulation | 21 CFR 892.1940 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every LHO clearance
Top LHO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Victoreen, Inc. | 3 | 1986-05-07 |
| Radiation Measurements, Inc. | 2 | 1987-10-30 |
| Varian Assoc., Inc. | 2 | 1985-07-01 |
| Standard Imaging, Inc. | 1 | 2004-11-15 |
Most recent LHO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K042733 | Standard Imaging, Inc. | STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEM | 2004-11-15 | 45 |
| K873956 | Radiation Measurements, Inc. | ULTIMETER | 1987-10-30 | 32 |
| K860260 | Victoreen, Inc. | MULTI PURPOSE MODEL 76-903 | 1986-05-07 | 103 |
| K853754 | Victoreen, Inc. | MAGNETIC RESONANCE IMAGING UNIFORMITY/T1 76-901 | 1986-05-07 | 240 |
| K860100 | Victoreen, Inc. | MRI SLICE THICKNESS & CONTIGUITY PHANTOM #76-902 | 1986-04-22 | 102 |
Recalls for LHO devices
2 product recalls in 2 recall events; 1 initiated in the last five years and 0 still open. Most recent: 2024-02-08.
| Year | Recalls |
|---|---|
| 2020 | 1 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code LHO?
LHO is the FDA product code for instrument, quality-assurance, radiologic. It is a Class I device, regulated under 21 CFR 892.1940 and reviewed by the Radiology panel.
What device class is LHO?
Class I, regulation 21 CFR 892.1940. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LHO?
Across 8 cleared submissions the average was 127 days from receipt to decision (median 102).
Which companies have the most LHO clearances?
Victoreen, Inc. (3); Radiation Measurements, Inc. (2); Varian Assoc., Inc. (2); Standard Imaging, Inc. (1).
Have LHO devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2024-02-08.
Next steps
- Run an FDA pathway report with predicate devices for product code LHO
- Run a recall and safety report across every LHO manufacturer
- Watch product code LHO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Radiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times