510(k) · Cleared
ClearedModification to Skylight Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Adac Laboratories · KPS System, Tomography, Computed, Emission
Cleared on Nov 6, 2001 as substantially equivalent to K000908 (Adac Laboratories, 2000) after a 15-day review. Its family tree reaches back 1 generation to 2000. 3 later devices descend from it.
- Decided
- Nov 6, 2001
- Review
- 15 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000908 (2000). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK000908 Skylight Imaging SystemAdac Laboratories · 2000 · Recalled
- This deviceK013496 Modification to Skylight Imaging SystemAdac Laboratories · 2001
- Descendant · cites it directly · 2 of its ownK031705 Skylight Imaging SystemAdac Laboratories · 2003
- Descendant · 2 generations on · 1 of its ownK041218 Griffin Spect/CT Imaging SystemAdac Laboratories · 2004 · Recalled
- Descendant · 3 generations on · 0 of its ownK051351 Precedence Spect/CT Imaging SystemAdac Laboratories · 2005 · Recalled
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 |
|---|---|---|---|---|---|
| −1 | K000908 | Skylight Imaging System | Adac Laboratories | 2000 | 13 |
| 0 (this device) | K013496 | Modification to Skylight Imaging System | Adac Laboratories | 2001 | — |
| +1 | K031705 | Skylight Imaging System | Adac Laboratories | 2003 | — |
| +2 | K041218 | Griffin Spect/CT Imaging System | Adac Laboratories | 2004 | 11 |
| +3 | K051351 | Precedence Spect/CT Imaging System | Adac Laboratories | 2005 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 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 KPS? 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 KPS device
- #1 K253564 uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI…score 18.6 · 17 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K000908 | Skylight Imaging SystemSummary page 1…omputed Tomography System Device Class: 21 CFR 892.1200, Class II Product Code: 90 KPS C. Date prepared: September 28, 2001 D. Predicate Device: SKYLight Imaging System (K000908) E. Intended Use: The SKYLight Imaging System is intended to produce images depicting the anatomical distributions of single ph… | 2000 |
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 |
|---|---|---|---|
| K031705 | Skylight Imaging System | 2003 | 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?
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KPS
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPS
65in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPS
16in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · KPS
36in 2025
MAUDE reports naming product code KPS, 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 | 8 | 38 | 22 | 38 |
| 2008 | 17 | 25 | 16 | 11 |
| 2009 | 9 | 42 | 14 | 15 |
| 2010 | 3 | 91 | 4 | 44 |
| 2011 | 7 | 28 | 34 | 56 |
| 2012 | 6 | 94 | 13 | 34 |
| 2013 | 11 | 84 | 13 | 240 |
| 2014 | 11 | 92 | 18 | 33 |
| 2015 | 3 | 112 | 5 | 24 |
| 2016 | 11 | 65 | 16 | 10 |
| 2017 | 11 | 104 | 11 | 31 |
| 2018 | 13 | 59 | 12 (3) | 26 |
| 2019 | 3 | 60 | 5 (5) | 105 |
| 2020 | 12 | 72 | 8 | 22 |
| 2021 | 15 | 66 | 4 | 10 |
| 2022 | 5 | 60 | 8 (6) | 15 |
| 2023 | 12 | 63 | 6 (3) | 22 |
| 2024 | 11 | 59 | 15 | 23 |
| 2025 | 12 | 65 | 16 | 36 |
| 2026 | 6 | 67 | 6 | — |
What is it indicated for?
The SKYLight Imaging System is intended to produce images depicting the anatomical
distribution of single photon and positron emitting radioisotopes within the body for
interpretation by medical personnel.
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/K013496 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013496: Modification to Skylight Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013496
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026