Concentriq Dx
FDA 510(k) K230839 · Proscia, Inc.
510(k) numberK230839
Submission
- Device name
- Concentriq Dx
- Applicant
- Proscia, Inc.
Philadelphia, PA, US - Received
- March 27, 2023
- Decision date
- February 8, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PSY – Whole Slide Imaging System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.3700
- Specialty
- Pathology
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…
Other 510(k)s with product code PSY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253554 | Aperio GT 450 DX; Aperio GT 180 DXPSY · Traditional | Leica Biosystems Imaging, Inc. | 08/07/2026SE |
| K260964 | NanoZoomer S540MD Slide Scanner SystemPSY · Abbreviated | Hamamatsu Photonics K.K. | 07/22/2026SE |
| K251952 | VirasightPSY · Traditional | Virasoft Corporation | 07/17/2026SE |
| K253606 | NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner systemPSY · Abbreviated | Hamamatsu Photonics K.K. | 07/15/2026SE |
| K243871 | Philips IntelliSite Pathology Solution 5.1PSY · Traditional | Philips Medical Systems Nederland B.V. | 03/06/2025SE |
| K241717 | E1000 Dx Digital Pathology SolutionPSY · Traditional | Shandon Diagnostics Limited | 02/28/2025SE |
| K242783 | Roche Digital Pathology DxPSY · Special | Ventana Medical Systems, Inc. | 12/17/2024SE |
| K242848 | Philips IntelliSite Pathology Solution 5.1PSY · Traditional | Philips Medical Systems Nederland B.V. | 12/10/2024SE |
| K241871 | Philips IntelliSite Pathology SolutionPSY · Traditional | Philips Medical Systems Nederland B.V. | 12/02/2024SE |
| K233204 | Philips IntelliSite Pathology Solution 5.1PSY · Traditional | Philips Medical Systems Nederland B.V. | 06/24/2024SE |
More from Philips Medical Systems Nederland B.V.
| 510(k) | Device | Decision |
|---|---|---|
| K261380 | Concentriq AP-DxQKQ · Traditional | 08/05/2026SE |
Questions and answers
When was Concentriq Dx cleared by the FDA?
Concentriq Dx (K230839) received a 510(k) decision of Substantially Equivalent on February 8, 2024, 318 days after the submission was received.
What is the product code of K230839?
The FDA product code is PSY – Whole Slide Imaging System, a Class II (moderate risk) device regulated under 21 CFR 864.3700.