510(k) · Cleared
ClearedConvergence Nua for Hitachi Spectradigital V250DSP Gamma Cameras
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hitachi Medical Corp. of America · KPS System, Tomography, Computed, Emission
Cleared on Jun 18, 1999 as substantially equivalent to K971878 (Adac Laboratories, 1997) after a 60-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Jun 18, 1999
- Review
- 60 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K943596 (1995). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K971878 | Vantage 2.1 ExspectSummary page 2…0 90KPS Trade/Proprietary Name: Convergencesv NUA sM for Hitachi SPECTRADiIgital™ V250DSP Gamma Cameras Predicate Device: ADAC Vantage ExSpect 2.1 system cleared under K971878 Device Description Function Convergences NUA s for Hitachi SPECTRADigital™ V250DSP Gamma Cameras is an optional Attenuation Cor… | 1997 |
| † | K954129 | Spectradigital Series V250DSP | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
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 4 years and passes through 2 companies; a new generation was cleared every 2.3 years on median.
- None of the 2 ancestors has a recall.
- 3 other devices also cite its predicate K971878.
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?
Intended uses of Convergences™ NUAs™ for Hitachi SPECTRADigital™ V250DSP Gamma Cameras is identical to the ADAC Vantage ExSPECT 2.1 cleared under K971878 in system function and operational software. These include: Acquisition of patient specific anatomic density via transmission imaging to determine attenuation coefficients applicable to emission slice data. Reconstruction of transmission and emission SPECT data via FBP and/or ML-EM/OSEM reconstruction…
Read the full statement (250 words)
Intended uses of Convergences™ NUAs™ for Hitachi SPECTRADigital™ V250DSP Gamma Cameras is identical to the ADAC Vantage ExSPECT 2.1 cleared under K971878 in system function and operational software. These include:
Acquisition of patient specific anatomic density via transmission imaging to determine attenuation coefficients applicable to emission slice data.
Reconstruction of transmission and emission SPECT data via FBP and/or ML-EM/OSEM reconstruction methods
Analysis and generation of attenuation maps and coefficients to apply to emission SPECT slice/volume sets.
The acquisition of SPECT is as cleared under SPECTRADigital™ Series V250DSP system K954129, with addition of transmission acquisition protocols to produce images which depict anatomical density of a patient. The device is intended to provide an enhancement to the emission images acquired SPECTRADigital™ Series V250DSP by correcting for attenuation and scatter effects in the patient. When resulting images are interpreted by a trained physician, the information provided can be useful in the diagnosis determination.
Imaging capabilities with Convergences® NUASM for Hitachi SPECTRADigital™ V250DSP Gamma Cameras option include:
All SPECT procedures in common practice including matrix based spatial framed, temporal/spatial list mode and angular projection mode static, gated and multi-orbit sampling
High and normal count-rate dynamic and non-temporal SPECT
In conjunction with additional options for Coincidence based imaging, the detector performance and NUASM acquisition and processing characteristics are available for non-uniform attenuation SPECT, attenuation correction in CID and CID based ECT imaging (these options are covered under separate and exclusive PMAS)
Multiple window sampled imaging, including scatter correction via single, dual or plural window processing.
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/K991318 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991318: Convergence Nua for Hitachi Spectradigital V250DSP Gamma Cameras.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991318
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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