# K991535: Convergence CDR for Hitachi Spectradigital V250DSP Gamma Cameras

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi Medical Corp. of America
- Decided: Jul 30, 1999 after 88 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 K952684 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952684: Vertex Epic MCD, Adac Laboratories (1995) Summary page 2.
- K971980: MCD-AC, Adac Laboratories (1997) Summary page 2.
- K982911: FORTE, Adac Laboratories (1998) Summary page 2.

## Indications for use
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.

Source page: https://510kreport.com/device/K991535
Methodology: https://510kreport.com/methodology