Home / 510(k) Clearances / K203720

510(k) K203720

MICROMATE by Isys Medizintechnik GmbH — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 2021
Date Received
December 21, 2020
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 Isys Medizintechnik GmbH

  • K230130 — Micromate™ Navi+ (October 10, 2023)
  • K131433 — ISYS 1 (U.S),ACCESSORY, NON-STERILE (March 11, 2014)

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)
  • K253520 — Photonova Spectra, Photonova Spectra Select (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)