510(k) · Cleared
ClearedConvergence CDR 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 Jul 30, 1999 as substantially equivalent to K952684 (Adac Laboratories, 1995) and 2 other predicates after an 88-day review. Its family tree reaches back 2 generations to 1995. 1 of the 4 devices in its family, counting itself, has a Class I recall.
- Decided
- Jul 30, 1999
- Review
- 88 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K952684 (1995). 3 ancestors in all. No later device cites it as a predicate yet. 1 of the 4 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK952684 Vertex Epic MCDAdac Laboratories · 1995 · Recalled
- 1 generation backK971980 MCD-ACAdac Laboratories · 1997
- This deviceK991535 Convergence CDR for Hitachi Spectradigital V250DSP Gamma CamerasHitachi Medical Corp. of America · 1999
Class I recalls in this family
- K982911 FORTEdirect predicate · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K952684 | Vertex Epic MCD | Adac Laboratories | 1995 | 2 |
| −1 | K971980 | MCD-AC | Adac Laboratories | 1997 | — |
| 0 (this device) | K991535 | Convergence CDR for Hitachi Spectradigital V250DSP Gamma Cameras | Hitachi Medical Corp. of America | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 1 |
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.
1 device in this family has 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? (3)
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 |
|---|---|---|---|
| * | K952684 | Vertex Epic MCDSummary page 2…tion Number: 892.1200 90KPS Trade/Proprietary Name: Convergences“CDR ™ for Hitachi SPECTRADiIgital™ V250DSP Gamma Cameras Predicate Device: ADAC EPIC-MCD cleared under K952684, ADAC MCD-AC cleared under K971980 and ADAC VERTEX Ultra cleared under K982911. Device Description Function CONVERGENCE=s» CDR… | 1995 |
| * | K971980 | MCD-ACSummary page 2…roprietary Name: Convergences“CDR ™ for Hitachi SPECTRADiIgital™ V250DSP Gamma Cameras Predicate Device: ADAC EPIC-MCD cleared under K952684, ADAC MCD-AC cleared under K971980 and ADAC VERTEX Ultra cleared under K982911. Device Description Function CONVERGENCE=s» CDR s™ for Hitachi SPECTRADiIgital™ V2… | 1997 |
| * | K982911 | FORTESummary page 2…chi SPECTRADiIgital™ V250DSP Gamma Cameras Predicate Device: ADAC EPIC-MCD cleared under K952684, ADAC MCD-AC cleared under K971980 and ADAC VERTEX Ultra cleared under K982911. Device Description Function CONVERGENCE=s» CDR s™ for Hitachi SPECTRADiIgital™ V250DSP Gamma Cameras, cleared under K954129 i… | 1998 |
| † | K954129 | Spectradigital Series V250DSP | 1995 |
| † | K991318 | Convergence Nua for Hitachi Spectradigital V250DSP Gamma Cameras | 1999 |
| † | K991129 | Hitachi Spectradigital V250DSP Gamma Camera System with Thick Nal (TI) Crystal | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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.
- K982911FORTEAdac Laboratories · 1998 · Direct predicate · ◆ in the 1998 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
- 2 of the 3 ancestors have a recall of any class; 1 has a Class I recall.
- 3 other devices also cite its predicate K952684.
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™ CDRs¥ for Hitachi SPECTRADigital™ V250DSP Gamma Cameras is identical to the principle of coincidence imaging used by EPIC-MCD cleared under K952684, ADAC MCD-AC cleared under K971980 in intended use, methods, reconstruction algorithms, transmission source type, and effectiveness of application. These include: Imaging Acquisition of patient specific biodistribution of positron-emitting radioisotopes in-vivo. Acquisition of…
Read the full statement (207 words)
Intended uses of Convergences™ CDRs¥ for Hitachi SPECTRADigital™ V250DSP Gamma Cameras is identical to the principle of coincidence imaging used by EPIC-MCD cleared under K952684, ADAC MCD-AC cleared under K971980 in intended use, methods, reconstruction algorithms, transmission source type, and effectiveness of application. These include:
Imaging
Acquisition of patient specific biodistribution of positron-emitting radioisotopes in-vivo.
Acquisition of patient specific anatomic density via transmission imaging to determine attenuation coefficients applicable to emission slice data.
Reformation of coincidence data to images frames with subsequent reconstruction of transmission and Wholebody ECT data via FBP and/or ML-EM/OSEM reconstruction methods.
Analysis and generation of attenuation maps and coefficients to apply to emission ECT slice/volume sets.
capabilities with Convergences™ CDRs™ 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
Use in conjunction with FDA approved 511 keV emitting radiopharmaceuticals
High and normal count-rate dynamic and non-temporal ECT
In conjunction with Coincidence based imaging, the detector performance and NUASM acquisition and processing characteristics are available for non-uniform attenuation ECT, attenuation correction in CID and CID based ECT imaging.
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/K991535 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991535: Convergence CDR for Hitachi Spectradigital V250DSP Gamma Cameras.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991535
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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