# K161918: SREE MRI Transport Incubator

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Imaging Research Dba Sree Medical Systems
- Decided: Mar 3, 2017 after 233 days
- Product code: FPL (Incubator, Neonatal Transport)
- Device class: 2
- Regulation: 21 CFR 880.5410
- 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 K001019 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062052: LMT Nomag IC 3.0, Lmt Lammers Medical Technology GmbH (2006) Summary page 4.
- K033565: LMT Nomag IC 1,5, Lmt Lammers Medical Technology GmbH (2003) Summary page 4.

## Indications for use
Indications for use are for pre-term, term newborns and small infants requiring a diagnostic MRI exam and need to be moved from their warm and controlled intensive care units to the MRI scanner. Indications for use are to maintain a warm and controlled environment during inter-departmental transport and during the MRI procedure. The SREE MRI Transport Incubator provides a warm and controlled environment during inter-departmental transport and during the diagnostic exam on a scanner with either 1.5T or 3T magnet field strengths. The SREE MRI Transport Incubator accommodates pre- and term newborns and infants up to 1 month of age and 4.5Kg whole body weight or 55cm whole body length (21.7”).

Source page: https://510kreport.com/device/K161918
Methodology: https://510kreport.com/methodology