System, Image Processing, Radiological
Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.
OpenFDA device adverse-event casebook.
FDA Class II (moderate risk, special controls required), regulated under 21 CFR §892.2050 (Radiology panel).
FDA MAUDE casebook
openFDA event book System, Image Processing, Radiological MID-BOOK · MAUDE
#145 of 1000 · 19,647 reports · 1996–2026
- BOOK 19,647 reports
- RANK #145 of 1000
- DEATH 41 death-typed
- INJ 124 injury-typed
- MALF 19,371 malfunction
- SPAN 1996–2026
- PEAK 2014: 15,631
- PHOTO Suture
Nearest event-volume peer: Suture, Nonabsorbable, Synthetic, Polypropylene (39 report gap)
System, Image Processing, Radiological sits #145 of 1000 among tracked device types with 19,647 MAUDE reports spanning 1996–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →
Malfunction reports run above the device-type norm
System, Image Processing, Radiological carries 98.6% MALFUNCTION-coded reports, 33.8pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
- INJ 0.6% corpus 30.3% · below corpus mean (-29.7 pp)
- MALF 98.6% corpus 64.8% · above corpus mean (+33.8 pp)
Lead product-problem code Nonstandard Device is 43% of coded problems · Lead manufacturer AGFA HEALTHCARE CORP accounts for 60% of manufacturer-tagged reports · Top event location is 96% of location-tagged rows .
System, Image Processing, Radiological in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Suture
Suture, Nonabsorbable, Synthetic, Polyethylene
20,010 reports
- Leadless Pace…
Leadless Pacemaker
19,964 reports
- Dorsal Root G…
Dorsal Root Ganglion Stimulator For Pain Relief
19,735 reports
- Suture
Suture, Nonabsorbable, Synthetic, Polypropylene
19,686 reports
- System (this)
System, Image Processing, Radiological
19,647 reports
- Impactor
Impactor
19,287 reports
What this shows System, Image Processing, Radiological carries 19,647 MAUDE reports, ranked #145 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports rose to 118 in 2025, up from an average of 34 in the two years before - a recent-year increase, not a lifetime pattern.
Related Entities for System, Image Processing, Radiological
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for System, Image Processing, Radiological: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.
Similar report volume
Nearest other device types by FDA MAUDE report count (19,647 here).
Similar death-typed counts
Nearest other device types by death-typed report count (41 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for System, Image Processing, Radiological are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.
Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for System, Image Processing, Radiological; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.