FDA product code · Radiology · Class 2
EHD: Unit, X-Ray, Extraoral With Timer
EHD is FDA's product code for "Unit, X-Ray, Extraoral With Timer": a Class 2 device classified under 21 CFR 872.1800, reviewed by the Radiology panel.
510(k) review time for EHD
Across 42 510(k) clearances under EHD decided from 2018-01-01 to 2026-10-06, the median was 100 days from FDA receipt to decision. Half took between 55 and 172 days, and 80% were decided within 184 days. These are past clearances, not a forecast for a new submission.
| Fastest | 18 |
|---|---|
| 25th percentile | 55 |
| Median | 100 |
| 75th percentile | 172 |
| 80th percentile | 184 |
| 90th percentile | 243 |
| Slowest | 448 |
| Year | Median days | n |
|---|---|---|
| 2018 | 30 | 5 |
| 2022 | 58 | 8 |
| 2023 | 147 | 8 |
| 2024 | 58 | 7 |
| 2026 (to 10-06, partial) | 128 | 6 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
EHD in the public FDA record
| 510(k) clearances, all years | 190 |
|---|---|
| Device recalls | 18 |
| Establishment listings | 103 |
| GUDID device identifiers | 1,009 |
Counts of records, not of devices or events. Adverse event reports for EHD are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite EHD
3 FDA recognized consensus standards cite EHD, among them IEC 61223-3-4 First edition 2000-03; IEC 60601-2-63 Edition 1.2 2021-05 CONSOLIDATED VERSION; IEC 60601-2-65 Edition 1.2 2021-05 CONSOLIDATED VERSION. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 12-221 IEC 61223-3-4 First edition 2000-03 — Evaluation and routine testing in medical imaging departments - Part 3-4: Acceptance tests - Imaging performance of dental X-ray
- 12-339 IEC 60601-2-63 Edition 1.2 2021-05 CONSOLIDATED VERSION — Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
- 12-340 IEC 60601-2-65 Edition 1.2 2021-05 CONSOLIDATED VERSION — Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral-X-ray equipment
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.