Chrysalis Intelligence · Sponsors · Intelerad Medical Systems Incorporated

Intelerad Medical Systems Incorporated

Montreal, CA · 1 510(k) clearances · 2 recalls

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Total clearances

1

2020-04-02 → 2020-04-02

Last 12 months

0

Product codes

1

Most recent

2020-04-02

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent
LLZ	System, Image Processing, Radiological	Class II	Radiology	1	2020-04-02

Safety

Recalls (2)

Class I (serious)

0

Risk of injury / death

Total recalls

2

Currently ongoing

2

Most recent

2025-10-17

Date	Severity	Status	Recall #	Product	Code	Reason
2025-10-17	Class II	Ongoing	Z-0723-2026	IntelePACS - InteleConnect / TechPortal	—	Software application that receives digital images and data to be communicated, processed, manipulated, enhanced, stored, displayed has a bug that could cause da…
2025-02-05	Class II	Ongoing	Z-1208-2025	IntelePACS (Image Fusion Module) - InteleViewer	—	A software application that receives digital images and data from various sources has a bug in specific software versions that will calculate the Standard Uptak…

Filings

All 510(k) clearances (1)

Date	K-number	Device	Code	Class	Specialty
2020-04-02	K192176	IntelePACS	LLZ	Class II	Radiology