Chrysalis Intelligence · Sponsors · Iba Dosimetry GmbH

Iba Dosimetry GmbH

Schwarzenbruck, DE · 2 510(k) clearances · 1 recalls

Total clearances
2
2020-01-23 → 2020-07-17
Last 12 months
0
Product codes
1
Most recent
2020-07-17
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
LHN System, Radiation Therapy, Charged-Particle, Medical Class II Radiology 2 2020-07-17
Safety

Recalls (1)

Class I (serious)
0
Risk of injury / death
Total recalls
1
Currently ongoing
1
Most recent
2025-04-01
DateSeverityStatusRecall # ProductCodeReason
2025-04-01 Class II Ongoing Z-1703-2025 myQA iON; Article Number: MQ10-000; Wrong analysis results can occur if the user creates two structures with the same name, except for one differing by a special character.
Filings

All 510(k) clearances (2)

Date K-number Device Code Class Specialty
2020-07-17 K201798 myQA iON LHN Class II Radiology
2020-01-23 K191821 Blue Phantom PT LHN Class II Radiology