510(k) · Cleared
ClearedAutomated Cellular Imaging System (Acis)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chroma Vision Medical Systems, Inc. · JOY Device, Automated Cell-Locating
Cleared on Jul 28, 1999 as substantially equivalent to K925670 (Intelligent Medica Imaging, Inc., 1993) after a 247-day review. Its family tree reaches back 1 generation to 1993. 14 later devices descend from it.
- Decided
- Jul 28, 1999
- Review
- 247 days
- Class
- Class II
- Product code
- JOY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K925670 (1993). 14 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK925670 IMS-200Intelligent Medica Imaging, Inc. · 1993
- This deviceK984188 Automated Cellular Imaging System (Acis)Chroma Vision Medical Systems, Inc. · 1999
- Descendant · cites it directly · 13 of its ownK030192 Duet SystemBioview, Ltd. · 2003
- Descendant · 2 generations on · 12 of its ownK040591 Duet SystemBioview, Ltd. · 2004
- Descendant · 2 generations on · 7 of its ownK050840 Modification to Duet SystemBioview, Ltd. · 2005
- Descendant · 2 generations on · 5 of its ownK061602 Duet SystemBioview, Ltd. · 2007
- Descendant · 3 generations on · 4 of its ownK050236 FishviewApplied Spectral Imaging, Ltd. · 2005
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K030192Duet SystemBioview, Ltd. · 2003 · cites it directly13descendants
- K040591Duet SystemBioview, Ltd. · 2004 · 2 generations on12descendants
- K050840Modification to Duet SystemBioview, Ltd. · 2005 · 2 generations on7descendants
- K061602Duet SystemBioview, Ltd. · 2007 · 2 generations on5descendants
- K050236FishviewApplied Spectral Imaging, Ltd. · 2005 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K925670 | IMS-200 | Intelligent Medica Imaging, Inc. | 1993 | — |
| 0 (this device) | K984188 | Automated Cellular Imaging System (Acis) | Chroma Vision Medical Systems, Inc. | 1999 | — |
| +1 | K030192 | Duet System | Bioview, Ltd. | 2003 | — |
| +2 | K040591 | Duet System | Bioview, Ltd. | 2004 | — |
| +2 | K050840 | Modification to Duet System | Bioview, Ltd. | 2005 | — |
| +2 | K061602 | Duet System | Bioview, Ltd. | 2007 | — |
| +3 | K050236 | Fishview | Applied Spectral Imaging, Ltd. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 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? (4)
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 |
|---|---|---|---|
| * | K925670 | IMS-200Summary page 2…with 21 CFR 864.3600. * Cell locating feature: Intelligent Imaging, Inc., Model IMS- 200, automated cell locating device found substantially equivalent on July 23, 1993(K925670/A). Such devices are classified under 21 CFR 864.5260. * Human manual visualization by conventional microscopy. 21 CFR 807.92(… | 1993 |
| * | — | Digital analyzer: ChromaVision Medical Systems, Inc.’s Model Named without a submission number | |
| * | — | Nikon Biostation Named without a submission number | |
| * | — | Human manual visualization by conventional microscopy Named without a submission number |
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030192 | Duet System | 2003 | 13 |
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?
How does its category compare?
All JOY devicesJOY Device, Automated Cell-Locating: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Automated Cellular Imaging System (ACIS) device is intended to detect, count, and classify cells of clinical interest based on recognition of cellular objects of particular color, size, and shape.
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/K984188 · printed Nov 6, 2026
Cite this page
510(k) Report. “K984188: Automated Cellular Imaging System (Acis).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984188
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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