# K991318: Convergence Nua for Hitachi Spectradigital V250DSP Gamma Cameras

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi Medical Corp. of America
- Decided: Jun 18, 1999 after 60 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K943596 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971878: Vantage 2.1 Exspect, Adac Laboratories (1997) Summary page 2.

## Indications for use
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.

Source page: https://510kreport.com/device/K991318
Methodology: https://510kreport.com/methodology