Product code QIH: 510(k) clearances and predicates
Product code QIH covers syngo.CT Brain Quantification. FDA lists 334 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
334 clearances on file under product code QIH. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 25 |
| 2023 | 45 |
| 2024 | 64 |
| 2025 | 94 |
| 2026 so far | 74 |
Recent clearances
Newest QIH clearances in the FDA index, with applicant and decision date:
- K260055, syngo.CT Brain Quantification, applicant Siemens Medical Solutions USA, Inc., decided 2026-09-25. FDA record
- K262390, BoneXpert, applicant Visiana, decided 2026-09-22. FDA record
- K261368, Rapid Platform (R6.7), applicant Ischemaview, Inc., decided 2026-09-21. FDA record
- K261623, EchoPAC Software Only / EchoPAC Plug-in (v211), applicant GE Medical Systems Ultrasound and Primary Care Diagnostics, decided 2026-09-16. FDA record
- K261677, Artificial Intelligence Renal Assessment (AIRA) Version 1, applicant Aramis Global AI Consultancies, LLC, decided 2026-09-15. FDA record
- K261795, Quicktome Software Suite, applicant Omniscient Neurotechnology Pty, Ltd., decided 2026-09-10. FDA record
- K260879, 4DM, applicant INVIA, LLC, decided 2026-09-10. FDA record
- K251417, ReVISION 2, applicant Argus Cognitive, Inc., decided 2026-09-09. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include BoneXpert, Rapid Platform (R6.7). Watch new QIH clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code QIH?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent QIH clearances include syngo.CT Brain Quantification.
How many 510(k) clearances use product code QIH?
334 at the time this page was generated, from openFDA records.
How do I find a predicate device under QIH?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new QIH clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.