FDA product code EHB: Collimator, X-Ray
EHB is the FDA product code for collimator, x-ray. It is a Class I device, regulated under 21 CFR 872.1840 and reviewed by the Radiology panel. FDA has cleared 5 510(k) submissions under EHB, from 5 different applicants. The average 510(k) review took 98 days (median 90).
Classification
| Field | Value |
|---|---|
| Device name | Collimator, X-Ray |
| Device class | Class I |
| Regulation | 21 CFR 872.1840 |
| Review panel | RA — Radiology |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every EHB clearance
Top EHB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Innovators, Inc. | 1 | 1992-09-25 |
| S.C.D.P.I. of Florida, Inc. | 1 | 1990-10-09 |
| Knochen Dental Laboratory | 1 | 1984-02-21 |
| Moyco Industries, Inc. | 1 | 1984-01-13 |
| General X-Ray, Inc. | 1 | 1978-12-04 |
Most recent EHB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K921355 | Innovators, Inc. | WINGMASTER | 1992-09-25 | 189 |
| K903012 | S.C.D.P.I. of Florida, Inc. | AUDIOPRAT ENDOSCOPE | 1990-10-09 | 90 |
| K834606 | Knochen Dental Laboratory | X-RAY COLLIMATOR X-CJD | 1984-02-21 | 55 |
| K833558 | Moyco Industries, Inc. | X-RAY SHIELD | 1984-01-13 | 92 |
| K781675 | General X-Ray, Inc. | X-RAY COLLIMATOR | 1978-12-04 | 66 |
Recalls for EHB devices
openFDA lists no recalls for product code EHB.
Frequently asked questions
What is FDA product code EHB?
EHB is the FDA product code for collimator, x-ray. It is a Class I device, regulated under 21 CFR 872.1840 and reviewed by the Radiology panel.
What device class is EHB?
Class I, regulation 21 CFR 872.1840. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EHB?
Across 5 cleared submissions the average was 98 days from receipt to decision (median 90).
Which companies have the most EHB clearances?
Innovators, Inc. (1); S.C.D.P.I. of Florida, Inc. (1); Knochen Dental Laboratory (1); Moyco Industries, Inc. (1); General X-Ray, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EHB
- Run a recall and safety report across every EHB manufacturer
- Watch product code EHB 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.
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