FDA.report

510(k) K232833

Device
HALO AP Dx
Applicant
Indica Labs, Inc.
510(k) number
K232833
Product code
PSY
Decision
Substantially Equivalent (SESE)
Decision date
2024-05-07
Date received
2023-09-13
Regulation
864.3700
Classification name
Whole Slide Imaging System
Medical specialty
Pathology
Review panel
Pathology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Michele Fredrickson
Address
8700 Education Pl. NW Bldg. B Albuquerque NM US 87114 87114

FDA Registration Numbers

Source Documents

510(k) summary PDF

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K233027NanoZoomer S360MD Slide scanner systemHamamatsu Photonics K.K.2023-12-22
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K203845Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V.2021-09-17
K203364MDPC-8127Barco N.V.2021-04-15
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