# K041602: Panorama 1.0T

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems North America, Inc.
- Decided: Jul 26, 2004 after 42 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 7 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K031815 (2003). 1 ancestor in all.
58 later devices descend from it; 2 cite it directly.
3 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031815: Intera-Sensation Family, Philips Medical Systems (2003) Summary page 1.

## Most influential descendants
- K052078: Achieva, Intera and Panorama 1.0 Release 2-Series (2005), 57 descendants of its own
- K063559: Achieva, Intera and Panorama 1.0T, Release 2.5 (2007), 53 descendants of its own
- K110151: Achieva R4 1.5T and Achieva R4 3.0T (2011), 34 descendants of its own
- K163116: Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 (2017), 19 descendants of its own
- K173079: Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4 (2018), 15 descendants of its own

## Recalls of this device
- Nov 17, 2023 · Class I · Z-0505-2024: Firm was informed of an event in which the structural integrity of the MR system components failed due to unintended excessive pressure buildup of helium gas during a magnet quench. If the system is u
- Dec 21, 2018 · Class II · Z-0898-2019: There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
- Dec 21, 2018 · Class II · Z-0917-2019: There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
- Mar 16, 2018 · Class II · Z-1434-2018: Potential risk for helium gas inside the MR examination room during a magnet quench
- Feb 5, 2010 · Not classified · Z-1458-2011: In the ExamCard MobiFlex the Patient Position is "Prone" which must be "Supine". The result is mislabeling of left and right side of the patient. If this is not detected by the operator there is a ris
- May 12, 2009 · Not classified · Z-0794-2011: The Accessory Cart contained magnetic material and is attracted to the magnet when bringing it close to the system.
- Apr 30, 2007 · Not classified · Z-0984-2007: Potential for gaseous helium to improperly vent, resulting in rupture of the magnet vessel and venting of helium into the MRI site.

## Indications for use
PANORAMA 1.OT is a Magnetic Resonance Diagnostic Device intended for general diagnostic use that produces transverse, sagittal, coronal and oblique cross-sectional images based upon 'H metabolites, and that displays the internal structure of the whole body. These images when interpreted by a trained physician, yield information that may assist in diagnosis.

Source page: https://510kreport.com/device/K041602
Methodology: https://510kreport.com/methodology