# Spectral CT

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/spectral-ct-jak>
- Manufacturer: [Philips Medical Systems Technologies](https://devicerts.com/manufacturers/philips-medical-systems-technologies) (Israel, FDA 510(k) applicant)
- Device class: Class II (US FDA)
- FDA product code: JAK

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K244008 · decision 2025-05-16 · decision SESE · status: Active

## Recalls

- Z-0078-2027 · Class II · ongoing · initiated 2026-08-21: Software issues may affect the safety and performance of Spectral CT system(s). The issues may result in image artifacts, wrong slice thickness, or unintended system motion.
- Z-3155-2026 · Class II · ongoing · initiated 2026-08-18: The Bolus tracking scan application may crash with a system error message. Bolus Tracker shots may continue to occur even if the contrast threshold is reached. This may result in the patient receiving additional radiation.
- Z-1317-2026 · Class II · ongoing · initiated 2026-01-07: As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.

## Identifiers

- 510(k) Number: K244008 [FDA 510(k)]
- FDA product code: JAK [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 892.1750 [FDA 510(k)]
- Advisory committee: Radiology [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: Spectral CT, Philips Medical Systems Technologies. deviCERTS medical device catalogue. https://devicerts.com/devices/spectral-ct-jak (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-11-08
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/spectral-ct-jak.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/spectral-ct-jak
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.