K232833 is an FDA 510(k) clearance for the HALO AP Dx. This device is classified as a Whole Slide Imaging System (Class II - Special Controls, product code PSY).
Submitted by Indica Labs, Inc. (Albuquerque, US). The FDA issued a Cleared decision on May 7, 2024, 237 days after receiving the submission on September 13, 2023.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.3700. 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)..
| 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 |
| Product Code | PSY - Whole Slide Imaging System |
| Device Class | Class II - 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). |