510(k) Report

FDA applicant

Applied Imaging Corp.

Santa Clara, CA7 decisions1990–20052 recalls

FDA records 7 decisions for Applied Imaging Corp. (Santa Clara, CA) from 1990 to 2005: 7 510(k) clearances. Most are in product codes NTH (System, Automated Scanning Microscope And…) and JOY (Device, Automated Cell-Locating). Its devices cite 1 predicate, 0 of them its own earlier devices. 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, hematology panel, where it files most

How often FDA has decided Applied Imaging Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Applied Imaging Corp. since 2007.

Recalls per year

2in 2016

2016: 2
2007high 2 (2016) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Applied Imaging Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Applied Imaging Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • NTHSystem, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ…2decisions
  • JOYDevice, Automated Cell-Locating2decisions
  • NOTMicroscope, Automated, Image Analysis, Operator Intervention1decision
  • NQNMicroscope, Automated, Image Analysis, Immunohistochemistry,Operator…1decision
  • LNJAnalyzer, Chromosome, Automated1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K043519Ariol Her-2/Neu FishApplied Imaging Corp. · 20051cites it
  • K031715Ariol Her-2/Neu IhcApplied Imaging Corp. · 20041cites it
  • K001420SlidescanApplied Imaging Corp. · 20001cites it
  • K042542Cytovision for Cep XYApplied Imaging Corp. · 20051cites it
  • K033200ARIOLApplied Imaging Corp. · 20041cites it
  • K902311Genevision - Computer Assisted Chromosome Karyo.Applied Imaging Corp. · 19901cites it

What has FDA decided for it lately?

  • K043519Ariol Her-2/Neu FishApplied Imaging Corp. · 20051 recall
  • K042542Cytovision for Cep XYApplied Imaging Corp. · 20051 recall
  • K033200ARIOLApplied Imaging Corp. · 20041 recall
  • K031715Ariol Her-2/Neu IhcApplied Imaging Corp. · 20041 recall
  • K001420SlidescanApplied Imaging Corp. · 2000
  • K980375Winscan Automated Imaging SystemApplied Imaging Corp. · 1998
  • K902311Genevision - Computer Assisted Chromosome Karyo.Applied Imaging Corp. · 1990

All 7 as Applied Imaging Corp. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K033200Ariol is an automated scanning microscope and image analysis system. It is intended for…May 6, 2016Class III
  • K042542CytoVision Image Analysis and Capture System, an automated cell-locating device. The…May 2, 2016Class III