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FDA 510(k)

Smart Stitching Software System, Image Processing, Radiological

K-Number: K163048 · 2017-07-28

ApplicantOsko, Inc.
Decision Date2017-07-28
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Smart Stitching Software System, Image Processing, Radiological is a medical device manufactured by Osko, Inc.. It received FDA 510(k) clearance on 2017-07-28 under approval number K163048. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Smart Stitching Software System, Image Processing, Radiological?

Smart Stitching Software System, Image Processing, Radiological is a medical device that received FDA 510(k) clearance on 2017-07-28. It is manufactured by Osko, Inc.. The 510(k) number is K163048.

When was Smart Stitching Software System, Image Processing, Radiological approved by the FDA?

Smart Stitching Software System, Image Processing, Radiological received FDA 510(k) clearance on 2017-07-28, under approval number K163048.

What company makes Smart Stitching Software System, Image Processing, Radiological?

Smart Stitching Software System, Image Processing, Radiological is manufactured by Osko, Inc..

What is the FDA product code for Smart Stitching Software System, Image Processing, Radiological?

The FDA product code for Smart Stitching Software System, Image Processing, Radiological is LLZ.

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Related PubMed Literature

PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 42174919 Automating Safety Surveillance for Software-Based Medical Devices: Insights from FDA MAUDE Data. Studies in health technology and informatics (2026) PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026) PMID: 41836285 A Case Study of AI-Enabled Software as a Medical Device Cleared by the FDA for Assessing Hemorrhage Risk Index (APPRAISE-HRI) after Trauma. NEJM AI (2025)

Other Devices by Osko, Inc.

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Official Source

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