FDA product code · Radiology · Class 2
IZI: System, X-Ray, Angiographic
IZI is FDA's product code for "System, X-Ray, Angiographic": a Class 2 device classified under 21 CFR 892.1600, reviewed by the Radiology panel.
510(k) review time for IZI
Across 16 510(k) clearances under IZI decided from 2018-01-01 to 2026-10-06, the median was 115 days from FDA receipt to decision. Half took between 86 and 220 days, and 80% were decided within 229 days. These are past clearances, not a forecast for a new submission.
| Fastest | 59 |
|---|---|
| 25th percentile | 86 |
| Median | 115 |
| 75th percentile | 220 |
| 80th percentile | 229 |
| 90th percentile | 267 |
| Slowest | 300 |
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.
IZI in the public FDA record
| 510(k) clearances, all years | 199 |
|---|---|
| Device recalls | 259 |
| Establishment listings | 374 |
Counts of records, not of devices or events. Adverse event reports for IZI 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 IZI
3 FDA recognized consensus standards cite IZI, 1 of them recognized only in part, among them NEMA XR 27 Amendment 1-2013; IEC 60601-2-54 Edition 2.0 2022-09; IEC 61223-3-8 Edition 1.0 2024-03. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 12-286 NEMA XR 27 Amendment 1-2013 — X-ray equipment for interventional procedures - User Quality Control Mode
- 12-348 IEC 60601-2-54 Edition 2.0 2022-09 (partial recognition) — Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
- 12-364 IEC 61223-3-8 Edition 1.0 2024-03 — Evaluation and routine testing in medical imaging departments - Part 3-8: Acceptance and constancy tests - Imaging performance of X-ray equipment for radiography and radioscopy
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.