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510(k) K253520

Photonova Spectra, Photonova Spectra Select by Ge Medical Systems, LLC — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2026
Date Received
November 12, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Tomography, Computed
Device Class
Class II
Regulation Number
892.1750
Review Panel
RA
Submission Type

Other clearances by Ge Medical Systems, LLC

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  • K251399 — SIGNA™ Sprint (September 11, 2025)
  • K250941 — Revolution Vibe (August 1, 2025)
  • K243667 — Sonic DL (June 5, 2025)
  • K250379 — SIGNA Prime Elite (March 17, 2025)
  • K241242 — SIGNA MAGNUS (October 17, 2024)
  • K233750 — ECG-less Cardiac (April 2, 2024)

Other clearances for product code JAK

  • K253649 — Spectral CT Verida Family (March 27, 2026)
  • K252992 — CT Rembra RT; CT Areta RT; CT Rembra (March 23, 2026)
  • K253686 — True Definition DL (March 23, 2026)
  • K253574 — SOMATOM X.cite; SOMATOM X.ceed (March 20, 2026)
  • K252249 — Extremity CT Imaging System (March 13, 2026)
  • K260078 — Aquilion ServeSP (TSX-307B) V2.0 (March 13, 2026)
  • K260167 — Bunkerhill Contrast AVC (March 6, 2026)
  • K260166 — Bunkerhill Contrast CAC (March 6, 2026)
  • K260169 — AV Cardiac CT (March 5, 2026)
  • K253173 — uCT 780 with uWS-CT-Dual Energy Analysis (January 20, 2026)