FDA product code PSY: Whole Slide Imaging System

PSY is the FDA product code for whole slide imaging system. It is a Class II device, regulated under 21 CFR 864.3700 and reviewed by the Pathology panel. FDA has cleared 22 510(k) submissions under PSY, 17 in the last five years, from 11 different applicants. The average 510(k) review took 195 days (median 238); 213 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 2 recalls for PSY devices, 2 initiated in the last five years.

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).

Classification

510(k) clearances per year for PSY

Compare with all 510(k) review times · Search every PSY clearance

Top PSY applicants

6 more applicants have PSY clearances. See the full list in Caduvo.

Most recent PSY clearances

Recalls for PSY devices

2 product recalls in 2 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2026-04-20.

HCPCS codes with matching descriptors

Text match between the FDA device name and CMS descriptors, not an official crosswalk:

• G0219 — Pet imaging whole body; melanoma for non-covered indications

Frequently asked questions

What is FDA product code PSY?

PSY is the FDA product code for whole slide imaging system. It is a Class II device, regulated under 21 CFR 864.3700 and reviewed by the Pathology panel.

What device class is PSY?

Class II, regulation 21 CFR 864.3700. Typical premarket route: 510(k).

How long does a 510(k) take for product code PSY?

Across 22 cleared submissions the average was 195 days from receipt to decision (median 238).

Which companies have the most PSY clearances?

Philips Medical Systems Nederland B.V. (6); Hamamatsu Photonics K.K. (4); Leica Biosystems Imaging, Inc. (3); Ventana Medical Systems, Inc. (2); Virasoft Corporation (1).

Have PSY devices been recalled?

Yes: 2 product recalls across 2 recall events; the most recent began 2026-04-20.

Next steps

• Run an FDA pathway report with predicate devices for product code PSY
• Run a recall and safety report across every PSY manufacturer
• Watch product code PSY for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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