# K090811: Inspira HD, Model: NL1000

- Pathway: 510(k) (Abbreviated)
- Applicant: Neurologica Corporation
- Decided: Aug 27, 2009 after 155 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: 3 generations back to K915470 (1992). 15 ancestors in all.
10 later devices descend from it; 1 cites it directly.
1 of 26 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022240: Mobile Millennium MG System, Ge Medical Systems, Inc. (2002) Summary page 2.
- K780395: Imager, Body Section, Radionuclide, Union Carbide Corp. (1978) Summary page 2.
- K051765: Ceretom, Model NL3000, Neurologica Corporation (2005) Summary page 2.

## Most influential descendants
- K102677: Bodytom NL 4000 (2011), 9 descendants of its own
- K170238: BodyTom Elite (2017), 4 descendants of its own
- K213649: BodyTom 64 (2022), 2 descendants of its own
- K131431: Airo CT System (2013), 2 descendants of its own
- K242811: BodyTom 64 (2025), 1 descendant of its own

## Indications for use
The inSPira HD is intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel for anatomy that can be imaged in the 21cm field of view, primarily brain.

Source page: https://510kreport.com/device/K090811
Methodology: https://510kreport.com/methodology