# K990491: Angio-CT Miyabi

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Apr 5, 1999 after 47 days
- Product code: IXI (Block, Beam-Shaping, Radiation Therapy)
- Device class: 2
- Regulation: 21 CFR 892.5710
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
33 later devices descend from it; 2 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) SOMATOM Plus 4: named in the summary without a submission number
- (no number) Multistar Plus systems with Koordinat M: named in the summary without a submission number

## Most influential descendants
- K991600: Somatom Plus 4 with Sliding Gantry Option (1999), 32 descendants of its own
- K051765: Ceretom, Model NL3000 (2005), 27 descendants of its own
- K090811: Inspira HD, Model: NL1000 (2009), 10 descendants of its own
- K102677: Bodytom NL 4000 (2011), 9 descendants of its own
- K171183: OmniTom (2017), 6 descendants of its own

## Indications for use
The SOMATOM Plus 4 is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes* taken at different angles. (*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous movement of the sliding gantry.) The Multistar Plus is a ceiling-suspended double C-arm for single plane general vascular imaging as well as interventional techniques. Angio-CT MIYABI is a combined system, which allows interventional radiological techniques, and whole body x-ray computed tomography scanning on a single patient without moving the patient from one table to another especially after or during interventional procedure performed under image intensified visualization (e.g. stenting, coiling, local chemical therapy, embolization).

Source page: https://510kreport.com/device/K990491
Methodology: https://510kreport.com/methodology