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Spectral CT

by Philips Medical Systems Technologies

510(k) K244008

Spectral CT is a medical device (FDA Class II; FDA product code JAK, System, X-Ray, Tomography, Computed) made by Philips Medical Systems Technologies, cleared under FDA 510(k) K244008 on 16 May 2025, active as of 8 Nov 2026. 3 FDA recalls are linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

3 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source FDA 510(k), synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK244008 Date16 May 2025ClearedStatusActive

Official records

Recalls

3 recalls · 3 ongoing · FDA

    • Ongoing Z-0078-2027 FDA Class II initiated 21 Aug 2026

    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.

    • Ongoing Z-3155-2026 FDA Class II initiated 18 Aug 2026

    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.

    • Ongoing Z-1317-2026 FDA Class II initiated 7 Jan 2026

    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.

Timeline

4 dated events

  1. Cleared FDA 510(k) K244008
  2. Recall initiated FDA recalls Z-1317-2026
  3. Recall initiated FDA recalls Z-3155-2026
  4. Recall initiated FDA recalls Z-0078-2027

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
JAK
FDA applicant
Philips Medical Systems Technologies , Ltd.
Device class
Class II
Regulation
21 CFR Part 892.1750
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Similar devices

Other devices filed under FDA product code JAK (System, X-Ray, Tomography, Computed).

Other devices from Philips Medical Systems Technologies