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510(k) K123599

INGENUITY DIGITAL PET/CT by Philips Healthcare (Cleveland) — Product Code KPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 2013
Date Received
November 21, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Tomography, Computed, Emission
Device Class
Class II
Regulation Number
892.1200
Review Panel
RA
Submission Type

Other clearances by Philips Healthcare (Cleveland)

  • K133674 — PHILIPS IQON SPECTRAL CT (November 21, 2014)
  • K131773 — BRILLIANCE ICT (September 24, 2013)
  • K123576 — IMR SOFTWARE APPLICATION (June 7, 2013)
  • K113483 — ITERATIVE RECONSTRUCTION TECHNIQUE SOFTWARE APPLICATION (September 26, 2012)
  • K103483 — INGENUITY TF PET/MR (November 23, 2011)

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  • K254001 — VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 4 (January 13, 2026)
  • K253844 — AnyScan 3.0 NM Scanner Family (December 30, 2025)
  • K251370 — Cartesion Prime (PCD-1000A/3) V10.21 (December 1, 2025)
  • K251401 — PennPET Explorer Positron Emission Tomograph (November 25, 2025)
  • K252477 — Hybrid Viewer (00859873006240) (September 9, 2025)
  • K250170 — PHAROS (August 15, 2025)
  • K251561 — Biograph Trinion (July 31, 2025)
  • K251839 — uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) (July 17, 2025)
  • K251671 — Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems (July 3, 2025)