Leica Biosystems Imaging, Inc.

FDA Device Registration & Listing · Vista, CA, US · Registration 3006791373

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3006791373
FEI Number
3006791373
Entity Name
Leica Biosystems Imaging, Inc.
City/State/Country
Vista, CA, US
Establishment Address
1360 Park Center Drive, Vista, CA 92081, US
Establishment Type(s)
Manufacture Device in the United States for Export Only
Owner / Operator
Leica Biosystems, division of Leica Microsystems, Inc. (Owner Number: 10054155)
Owner / Operator Contact Address
21440 W. Lake Cook Road, Floor 5, Deer Park, IL 60010, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Aperio HALO AP DX

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QKQ Digital Pathology Image Viewing And Management Software Pathology Class 2 864.3700 2026-03-31
PSY Whole Slide Imaging System Pathology Class 2 864.3700 2024-02-09

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Leica Biosystems, division of Leica Microsystems, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
8020030 LEICA BIOSYSTEMS MELBOURNE PTY LTD MELBOURNE Victoria, AU
8010478 LEICA BIOSYSTEMS NUSSLOCH GMBH NUSSLOCH Baden-Wurttemberg, DE
3004859032 LEICA BIOSYSTEMS NEWCASTLE LTD NEWCASTLE UPON TYNE, GB
3006610913 LEICA MICROSYSTEMS LTD SHANGHAI China (Shanghai) Pilot Free Trade Zone, CN
1419341 Leica Biosystems Richmond, Inc. Richmond, IL, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K243871 Philips Medical Systems Nederland B.V. Philips IntelliSite Pathology Solution 5.1 2025-03-06

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006791373. Last updated year: 2026. Please use registration number 3006791373 when referencing this establishment in official correspondence.
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