HALO AP Dx
Indica Labs, LLC · K252762
FDA-authorized Predetermined Change Control Plan
- Company
- Indica Labs, LLC
- 510(k)/De Novo #
- K252762
- Decision date
- 2025-11-25
- Panel
- Pathology
- Pathway
- 510(k)
- Category
- Non-AI
- PCCP type
- Compatibility expansion
- Monitoring commitment
- Unknown
What this PCCP covers. Permits compatibility expansion to additional hardware
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- K242244Viewer+Lumea, Inc.2025-03-14Non-AIUnknown
Want the monitoring teardown?
We read the PCCP for HALO AP Dx, then map the post-market monitoring that its modification protocol requires, including the deployment-period evidence most teams can't reconstruct at modification time. Sentir is the independent system of record that produces it.
Book a callSource: U.S. FDA public records (openFDA 510(k)/De Novo databases and accessdata.fda.gov). PCCP type and category are editorial classifications based on public documents, not official FDA designations.
This page is a factual summary of public FDA records. Sentir Health is not affiliated with or endorsed by the named companies or the U.S. Food and Drug Administration. Spot an error? Request a correction.