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510(k) K121429

AIMAGO EASYLDI MICROCIRCULATION CAMERA by Aimago SA — Product Code DPT

K121429 is an FDA 510(k) premarket notification submitted by Aimago SA for the device "AIMAGO EASYLDI MICROCIRCULATION CAMERA". The FDA issued a decision of Substantially Equivalent on August 10, 2012. The device falls under product code DPT (Probe, Blood-Flow, Extravascular), a Class II device regulated under 21 CFR 870.2120. Aimago SA has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 2012
Date Received
May 14, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Probe, Blood-Flow, Extravascular
Device Class
Class II
Regulation Number
870.2120
Review Panel
CV
Submission Type

Other clearances by Aimago SA

  • K123216 — AIMAGO EASYLDI MICROCIRCULATION CAMERA (STAND PLUS CAMERA ARM), AIMAGO EASY LDI (February 7, 2013)

Other clearances for product code DPT

  • K233076 — Laser Speckle Imaging System (RFLSI CZW) (May 28, 2024)
  • K163339 — SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0 (August 17, 2017)
  • K152749 — moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution Infrared (May 12, 2016)
  • K142932 — Deltex Medical KDP72 Doppler Probe (January 22, 2015)
  • K132730 — BIO-PROBE DISPOSABLE INSERT WITH; BALANCE BIOSURFACE, CARMEDA BIOACTIVE SURFACE (May 30, 2014)
  • K133903 — BIO-PROBE TRANSDUCER (ADULT) (April 10, 2014)
  • K132163 — MOORLDLS-BI LASER DOPPLER BURNS IMAGER (January 29, 2014)
  • K124049 — DEEPVIEW DIGITAL VIDEO PHYSIOLOGICAL PORTABLE IMAGING SYSTEM (April 18, 2013)
  • K123216 — AIMAGO EASYLDI MICROCIRCULATION CAMERA (STAND PLUS CAMERA ARM), AIMAGO EASY LDI (February 7, 2013)
  • K122943 — MOORFLPI-2 FULL-FIELD LASER PERFUSION IMAGER (January 3, 2013)

FDA data resources