Cleared Traditional

K122554 - GENASIS SCANVIEW SYSTEM

K122554 is an FDA 510(k) clearance for GENASIS SCANVIEW SYSTEM, manufactured by Applied Spectral Imaging , Ltd.. The device is a Class 2 Pathology device with product code NTH cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K122554 · Applied Spectral Imaging , Ltd. · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2013
Decision
170d
Days
Class 2
Risk

K122554 is an FDA 510(k) clearance for the GENASIS SCANVIEW SYSTEM. Classified as System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (fish) Assays (product code NTH), Class II - Special Controls.

Submitted by Applied Spectral Imaging , Ltd. (Caesarea, IL). The FDA issued a Cleared decision on February 7, 2013 after a review of 170 days - an extended review cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 866.4700 - the FDA pathology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Pathology review framework, consistent with the majority of Class II 510(k) submissions.

View all Applied Spectral Imaging , Ltd. devices

FDA 510(k) Submission Details - K122554

510(k) Number K122554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2012
Decision Date February 07, 2013
Days to Decision 170 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d slower than avg
Panel avg: 77d · This submission: 170d
Pathway characteristics
Predicate-based equivalence.

NTH Device Classification - Class 2, Special Controls

Product Code NTH System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (fish) Assays
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.4700
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Pathology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01620853 Completed Observational Industry-sponsored

Detection of Chromosomal Aberrations in Non-small Cell Lung Cancer (NSCLC) Using Fluorescent in Situ Hybridization (FISH) (ALK Test)

Concordance Study for Detection of Chromosomal Aberrations Using FISH (ALK Test)in Non-small Cell Lung Cancer (NSCLC)

1
Patients (actual)
1
Site
Condition studied Non-small Cell Lung Cancer (NSCLC)
Eligibility All sexes · 20 Years+
Sponsor Applied Spectral Imaging Ltd. (industry)
Started 2012-05-01 → Primary completion 2013-01-01
Primary outcome
IVD study
Study completed - no results published. This trial concluded in 2013 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - NTH System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (fish) Assays

Devices cleared under the same product code (NTH) and FDA review panel - the closest regulatory comparables to K122554.
DUET SYSTEM
K130775 · Bioview , Ltd. · May 2014
SCANVIEW SYSTEM
K110345 · Applied Spectral Imaging · Oct 2011
ARIOL HER-2/NEU FISH
K043519 · Applied Imaging Corp. · Apr 2005
CYTOVISION FOR CEP XY
K042542 · Applied Imaging Corp. · Jan 2005