FDA.reportPublic FDA data

Aperio HALO AP DX

Primary DI
00815477020877
Brand
Aperio HALO AP DX
Company
LEICA BIOSYSTEMS IMAGING, INC
Model
23HALOAPDX
Device description
Aperio HALO AP DX, version 2.4 (abbreviated as v2.4) is an image and case management browser-based software with an integrated image viewer. It is used within a pathology laboratory to organize and present scanned whole slide images for a patient’s case to the intended users. The user can then open specific slide images from the case and view, manipulate, and annotate the images on the diagnostic display monitor
Published
2026-10-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
QKQDigital Pathology Image Viewing And Management Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QKQDigital Pathology Image Viewing And Management SoftwarePathology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252762000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252762000HALO AP DxIndica Labs, LLC2025-11-25QKQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815477020877PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815477020877008154770208778154770208770815477020877

Contacts#

Phone, Email table
PhoneEmail
+1 844 534 2262TechServices@leicabiosystems.com

Regulatory Flags#

DUNS number
063440460
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815477020686Aperio GT 180 DX23GT180DXUS2026-10-22
00815477020693Aperio iQC DX Software23iQCDXUS2026-10-22
00815477020259Aperio AT2 DX Scanner23AT2DX2020-01-23
00815477020051eIHC IVD bundle CS2- 250023CS2IVD-25002016-09-19
00815477020068eIHC IVD bundle AT Turbo-250023ATTIVD-25002016-09-19
00815477020525Aperio GT 450 DX (US) Scanner23GT450DXUS2024-05-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719896180012JelloXJelloX Biotech Inc.QKQ2026-05-18
07350092810685Sectra Digital Pathology ModuleSectra ABQKQ2026-05-12
G264APDX240HALO AP DxIndica Labs, Inc.QKQ2026-03-27
08809278790291INFINITT DPSINFINITT Healthcare Co.,Ltd.QKQ2026-01-29
00860012592500PathPresenter Clinical ViewerPathPresenter, CorporationQKQ2025-08-11
03760408001005CaloPixTRIBUN HEALTHQKQ2025-07-15
00860006696221AISight DxPathAI, Inc.QKQ2025-07-08
07350092810593Sectra Digital Pathology ModuleSectra ABQKQ2025-04-09
05051663010467EprediaSHANDON DIAGNOSTICS LIMITEDQKQ2025-03-10
00860006054557Concentriq AP-Dx-US Proscia Inc.QKQ2025-01-15
07350092810524Sectra Digital Pathology ModuleSectra ABQKQ2024-10-11
00860006054519Concentriq AP-DxProscia Inc.QKQ2024-08-26
07350092810500Sectra Digital Pathology ModuleSectra ABQKQ2024-05-07
07350092810487Sectra Digital Pathology ModuleSectra ABQKQ2023-11-13
07350092810456Sectra Digital Pathology ModuleSectra ABQKQ2023-06-21
00854904006039Synapse PathologyFujifilm Healthcare Americas CorporationQKQ2023-06-16
07350092810425Sectra Digital Pathology ModuleSectra ABQKQ2022-10-17
00860007120206Dynamyx Digital Pathology SoftwareOMNYX, LLCQKQ2022-04-21
07350092810388Sectra Digital Pathology ModuleSectra ABQKQ2022-03-30
00860007599101FullFocusTM Whole Slide Image ViewerPAIGE.AI, INC.QKQ2021-09-23
07350092810333Sectra Digital Pathology ModuleSectra ABQKQ2021-05-05
07350092810289Sectra Digital Pathology ModuleSectra ABQKQ2020-10-09
07350092810241Sectra Digital Pathology ModuleSectra ABQKQ2020-04-21
07350092810197Sectra Digital Pathology ModuleSectra ABQKQ2020-04-20