510(k) · Cleared
Recalled · Class I · 2019FORTE
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 16, 1998 after a 90-day review. The FDA summary names its predicate without a number. 4 of the 6 devices in its family, counting itself, have a Class I recall. 5 later devices descend from it. It has been recalled 3 times, including 2 Class I recalls.
- Decided
- Nov 16, 1998
- Review
- 90 days
- Class
- Class II
- Product code
- KPS
- Recalls
- 3 (2 Class I)
- Predicates
- 0
5 later devices descend from it, 2 citing it directly. 4 of the 6 devices in this family, counting this one, have a Class I recall.
- This deviceK982911 FORTEAdac Laboratories · 1998
- Descendant · cites it directly · 3 of its ownK033254 Forte Gamma Camera SystemAdac Laboratories · 2003 · Recalled (Class I)
- Descendant · 2 generations on · 2 of its ownK062298 Apollo Gamma Camera SystemAdac Laboratories · 2006 · Recalled (Class I)
- Descendant · 3 generations on · 1 of its ownK080927 Brightview VCT Imaging SystemPhilips Medical Systems (Cleveland), Inc. · 2008 · Recalled (Class I)
- Descendant · 4 generations on · 0 of its ownK083649 Cardius 3 X-ActDigirad Corp. · 2009
- Descendant · cites it directly · 0 of its ownK991535 Convergence CDR for Hitachi Spectradigital V250DSP Gamma CamerasHitachi Medical Corp. of America · 1999
Class I recalls in this family
Most influential descendants
Showing 5 of 5 · See all- K033254Forte Gamma Camera SystemAdac Laboratories · 2003 · cites it directly3descendants
- K062298Apollo Gamma Camera SystemAdac Laboratories · 2006 · 2 generations on2descendants
- K080927Brightview VCT Imaging SystemPhilips Medical Systems (Cleveland), Inc. · 2008 · 3 generations on1descendant
- K083649Cardius 3 X-ActDigirad Corp. · 2009 · 4 generations on0descendants
- K991535Convergence CDR for Hitachi Spectradigital V250DSP Gamma CamerasHitachi Medical Corp. of America · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K982911 | FORTE | Adac Laboratories | 1998 | — |
| +1 | K033254 | Forte Gamma Camera System | Adac Laboratories | 2003 | Class I |
| +2 | K062298 | Apollo Gamma Camera System | Adac Laboratories | 2006 | Class I |
| +3 | K080927 | Brightview VCT Imaging System | Philips Medical Systems (Cleveland), Inc. | 2008 | Class I |
| +4 | K083649 | Cardius 3 X-Act | Digirad Corp. | 2009 | — |
| +1 | K991535 | Convergence CDR for Hitachi Spectradigital V250DSP Gamma Cameras | Hitachi Medical Corp. of America | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2003 | 1 | 1 |
| 2006 | 1 | 1 |
| 2008 | 1 | 1 |
| 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.
4 devices in this family have a Class I recall. 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? (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 |
|---|---|---|---|
| * | — | Siemens E.CAM Profile AC Named without a submission number | |
| * | — | Millennium MT & MG Named without a submission number |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 19, 2019 | Class I | Z-0213-2020 | Nonconforming Material/Component | An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its travel limit. |
| Sep 19, 2019 | Class I | Z-0216-2020 | Nonconforming Material/Component | An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its travel limit. |
| Mar 6, 2015 | Class II | Z-1774-2015 | Nonconforming Material/Component | The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K033254Forte Gamma Camera SystemAdac Laboratories · 2003 · Cites it directly · ◆ in the 2003 descendants bar of FIG. 13 Class I recalls
- K062298Apollo Gamma Camera SystemAdac Laboratories · 2006 · 2 generations on · ◆ in the 2006 descendants bar of FIG. 11 Class I recall
- K080927Brightview VCT Imaging SystemPhilips Medical Systems (Cleveland), Inc. · 2008 · 3 generations on · ◆ in the 2008 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K033254 (Adac Laboratories, 2003) has gone furthest, with 3 descendants of its own.
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?
Vertex Ultra is intended to produce images depicting the anatomical distribution
of single photon and positron emitting radioisotopes within the human 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/K982911 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982911: FORTE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982911
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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