# K991129: Hitachi Spectradigital V250DSP Gamma Camera System with Thick Nal (TI) Crystal

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi Medical Corp. of America
- Decided: May 13, 1999 after 41 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: 1 generation back to K954129 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954129: Spectradigital Series V250DSP, Hitachi Medical Corp. of America (1995) Summary page 2.

## Indications for use
The SPECTRADigital™Series V250DSP system with 5/8" crystal option are identical to the intended uses of the SPECTRADigital™Series V250DSP camera cleared under K954129 including acquisition of SPECT, planar, and wholebody imaging of all organ systems utilizing FDA approved radiopharmaceuticals in the energy range from 50 to 511 keV. When resulting images are interpreted by a trained physician, the information provided can be useful in the diagnosis determination. Imaging capabilities with the Thick Crystal (5/8") Nal(Tl) option include: = All SPECT and Planar 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 planar and SPECT L In conjunction with additional options for Coincidence and transmission based imaging, the detector performance and 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 PMASs) = Multiple window sampled imaging, including scatter correction via single, dual or plural window processing.

Source page: https://510kreport.com/device/K991129
Methodology: https://510kreport.com/methodology