510(k) · Cleared
ClearedScanview, Model SC-300
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Applied Spectral Imaging, Ltd. · JOY Device, Automated Cell-Locating
Cleared on Oct 4, 2007 as substantially equivalent to K050236 (Applied Spectral Imaging, Ltd., 2005) and 1 other predicate after a 136-day review. Its family tree reaches back 5 generations to 1993. 3 later devices descend from it.
- Decided
- Oct 4, 2007
- Review
- 136 days
- Class
- Class II
- Product code
- JOY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K925670 (1993). 10 ancestors in all, the oldest K902311 (1990). 3 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK925670 IMS-200Intelligent Medica Imaging, Inc. · 1993
- 4 generations backK984188 Automated Cellular Imaging System (Acis)Chroma Vision Medical Systems, Inc. · 1999
- 3 generations backK030192 Duet SystemBioview, Ltd. · 2003
- 2 generations backK040591 Duet SystemBioview, Ltd. · 2004
- 1 generation backK050236 FishviewApplied Spectral Imaging, Ltd. · 2005
- This deviceK071398 Scanview, Model SC-300Applied Spectral Imaging, Ltd. · 2007
- Descendant · cites it directly · 2 of its ownK101291 Scanview HER2/Neu Fish SystemApplied Spectral Imaging, Ltd. · 2010
- Descendant · 2 generations on · 1 of its ownK110345 Scanview SystemApplied Spectral Imaging · 2011
- Descendant · 3 generations on · 0 of its ownK122554 Genasis Scanview SystemApplied Spectral Imaging, Ltd. · 2013
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K925670 | IMS-200 | Intelligent Medica Imaging, Inc. | 1993 | — |
| −4 | K984188 | Automated Cellular Imaging System (Acis) | Chroma Vision Medical Systems, Inc. | 1999 | — |
| −3 | K030192 | Duet System | Bioview, Ltd. | 2003 | — |
| −2 | K040591 | Duet System | Bioview, Ltd. | 2004 | — |
| −1 | K050236 | Fishview | Applied Spectral Imaging, Ltd. | 2005 | — |
| 0 (this device) | K071398 | Scanview, Model SC-300 | Applied Spectral Imaging, Ltd. | 2007 | — |
| +1 | K101291 | Scanview HER2/Neu Fish System | Applied Spectral Imaging, Ltd. | 2010 | — |
| +2 | K110345 | Scanview System | Applied Spectral Imaging | 2011 | — |
| +3 | K122554 | Genasis Scanview System | Applied Spectral Imaging, Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JOY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JOY device
- #1 K243144 X100/X100HT with Full Field Peripheral Blood…score 11.1 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K050236 | FishviewSummary page 1…umeration systems Regulatory class: Class 11 Reason for 510(k) Submission Traditional 510(k) Submission Identification of Legally Marketed Equivalent Devices FISHView K050236 and CytoVision CEP XY K042542 Device Description The ScanView System is an integrated digital imaging system constructed of an e… | 2005 |
| * | K042542 | Cytovision for Cep XYSummary page 1…class: Class 11 Reason for 510(k) Submission Traditional 510(k) Submission Identification of Legally Marketed Equivalent Devices FISHView K050236 and CytoVision CEP XY K042542 Device Description The ScanView System is an integrated digital imaging system constructed of an external microscope, motorized… | 2005 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101291 | Scanview HER2/Neu Fish System | 2010 | 2 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K101291 (Applied Spectral Imaging, Ltd., 2010) has gone furthest, with 2 descendants of its own.
How does its category compare?
All JOY devicesJOY Device, Automated Cell-Locating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · JOY
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JOY
136in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JOY
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JOY
1in 2025
MAUDE reports naming product code JOY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 136 | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 1 | — | 1 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ScanView System is an automated scanning microscope and image analysis system. It is intended for in-vitro diagnostic use as an aiding tool to the pathologist or cytogeneticist in the detection, classification and enumeration of cells of interest based on color, intensity, size, pattern, and shape. The ScanView is indicated to detect the following cell types:
CEP® X Spectrum Orange™/CEP® Y Spectrum Green™ DNA Probe kit (Vysis, Inc. Downer's Grove, IL) and is limited to the analysis of CEP XY probes via high-magnification capture and analysis of interphase nuclei. CEP XY .is indicated for use to assess the effectiveness of bone marrow transplantation in opposite-sex transplants.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K071398 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071398: Scanview, Model SC-300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071398
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026