510(k) · Cleared
ClearedColorpoint 1720 Medical Imagers and Video Capture Box CX-1000 Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Seiko Instruments USA, Inc. · LMC Camera, Multi Format, Radiological
Cleared on Jun 30, 1999 as substantially equivalent to K971760 (Seiko Instruments USA, Inc., 1997) after a 77-day review. Its family tree reaches back 1 generation to 1997. 4 later devices descend from it.
- Decided
- Jun 30, 1999
- Review
- 77 days
- Class
- Class II
- Product code
- LMC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K971760 (1997). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK971760 Colorpoint or Professional ColorpointSeiko Instruments USA, Inc. · 1997
- This deviceK991282 Colorpoint 1720 Medical Imagers and Video Capture Box CX-1000 SeriesSeiko Instruments USA, Inc. · 1999
- Descendant · cites it directly · 3 of its ownK030690 Codonics EP-1000 Medical Color Dry ImagersCodonics, Inc. · 2003
- Descendant · cites it directly · 1 of its ownK042232 NP-2600 Series Hardcopy PrintersCodonics, Inc. · 2004
- Descendant · 2 generations on · 0 of its ownK092280 Cypher Dicom Print SolutionVirtual Imaging, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK042159 Kodak Color Medical Imager 1000Eastman Kodak Company · 2004
Most influential descendants
Showing 4 of 4 · See all- K030690Codonics EP-1000 Medical Color Dry ImagersCodonics, Inc. · 2003 · cites it directly3descendants
- K042232NP-2600 Series Hardcopy PrintersCodonics, Inc. · 2004 · cites it directly1descendant
- K092280Cypher Dicom Print SolutionVirtual Imaging, Inc. · 2009 · 2 generations on0descendants
- K042159Kodak Color Medical Imager 1000Eastman Kodak Company · 2004 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K971760 | Colorpoint or Professional Colorpoint | Seiko Instruments USA, Inc. | 1997 | — |
| 0 (this device) | K991282 | Colorpoint 1720 Medical Imagers and Video Capture Box CX-1000 Series | Seiko Instruments USA, Inc. | 1999 | — |
| +1 | K030690 | Codonics EP-1000 Medical Color Dry Imagers | Codonics, Inc. | 2003 | — |
| +1 | K042232 | NP-2600 Series Hardcopy Printers | Codonics, Inc. | 2004 | — |
| +2 | K092280 | Cypher Dicom Print Solution | Virtual Imaging, Inc. | 2009 | — |
| +2 | K042159 | Kodak Color Medical Imager 1000 | Eastman Kodak Company | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2009 | 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 LMC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K971760 | Colorpoint or Professional ColorpointSummary page 1…ure Device Classification Name: Camera, Multiformat Predicate Device: Manufacturer: Seiko Instruments Inc. Device: ColorPoint™ Model 820 Medical imager 510(k) Number: K971760 Date Received: 05/12/197 Decision Date: 10/01/97 Decision: Substantially Equivalent Panel Code device reviewed by: Radiology… | 1997 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Its one ancestor has no recall.
- Of its descendants, K030690 (Codonics, Inc., 2003) has gone furthest, with 3 descendants of its own.
How does its category compare?
All LMC devicesLMC Camera, Multi Format, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LMC
2in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · LMC
80in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LMC
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LMC
2in 2018
MAUDE reports naming product code LMC, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 1 | 0 |
| 2009 | 3 | 80 | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Seiko ColorPoint™ model 1700 medical imager & Video Capture Box systems are indicated for converting the electronic signals from medical imaging modalities into hard copy suitable for diagnosis and record keeping.
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/K991282 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991282: Colorpoint 1720 Medical Imagers and Video Capture Box CX-1000 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991282
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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