Cleared Traditional

K232833 - HALO AP Dx (FDA 510(k) Clearance)

Class II Pathology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K232833 · Indica Labs, Inc. · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2024
Decision
237d
Days
Class 2
Risk

K232833 is an FDA 510(k) clearance for the HALO AP Dx. Classified as Whole Slide Imaging System (product code PSY), Class II - Special Controls.

Submitted by Indica Labs, Inc. (Albuquerque, US). The FDA issued a Cleared decision on May 7, 2024 after a review of 237 days - an extended review cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.3700 - the FDA pathology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Pathology review framework, consistent with the majority of Class II 510(k) submissions.

View all Indica Labs, Inc. devices

Submission Details

510(k) Number K232833 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2023
Decision Date May 07, 2024
Days to Decision 237 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
160d slower than avg
Panel avg: 77d · This submission: 237d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PSY Whole Slide Imaging System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.3700
Definition The Whole Slide Imaging System Is An Automated Digital Slide Creation, Viewing, And Management System Intended As An Aid To The Pathologist To Review And Interpret Digital Images Of Surgical Pathology Slides Prepared From Formalin-fixed, Paraffin-embedded (ffpe) Tissue. The System Generates Digital Images That Would Otherwise Be Appropriate For Manual Visualization By Conventional Brightfield Microscopy. The Whole Slide Imaging System Is Not Intended For Use With Slides Prepared From Frozen Tissue, Cytology, And Non-ffpe Hematopathology Specimens (e.g., Peripheral Blood Smear).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Pathology devices follow this clearance model.

Regulatory Peers - PSY Whole Slide Imaging System

All 18
Devices cleared under the same product code (PSY) and FDA review panel - the closest regulatory comparables to K232833.
Philips IntelliSite Pathology Solution 5.1
K243871 · Philips Medical Systems Nederland B.V. · Mar 2025
E1000 Dx Digital Pathology Solution
K241717 · Shandon Diagnostics Limited · Feb 2025
Roche Digital Pathology Dx
K242783 · Ventana Medical Systems, Inc. · Dec 2024
Philips IntelliSite Pathology Solution 5.1
K242848 · Philips Medical Systems Nederland B.V. · Dec 2024
Philips IntelliSite Pathology Solution
K241871 · Philips Medical Systems Nederland B.V. · Dec 2024
Philips IntelliSite Pathology Solution 5.1
K233204 · Philips Medical Systems Nederland B.V. · Jun 2024