# K963262: Artoscan M

- Pathway: 510(k) (Traditional)
- Applicant: Biosound, Inc.
- Decided: Mar 28, 1997 after 220 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- 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 K911667 (1991). 10 ancestors in all.
51 later devices descend from it; 3 cite it directly.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931022: Artoscan, Biosound, Inc. (1993) Summary page 2.
- K931008: Model #QWH-63, Quadrature Wrist and Hand Coil, Mri Devices Corp. (1993) Summary page 2.
- K911667: Hitachi MRP-7000 Magnetic Rosonance Device, Hitachi Medical Systems America, Inc. (1991) Summary page 2.
- K934396: Quadrature Lower Extremity Coil, Medical Advances, Inc. (1993) Summary page 2.
- K935661: Magnetom Open, Siemens Medical Solutions USA, Inc. (1994) Summary page 2.
- K911642: MRP-5000 and MRP-7000 Multiplanar Reconstruction, Hitachi Medical Systems America, Inc. (1991) Summary page 2.
- K940534: Gyroscan T10-NT (Release 4 Series Software), Philips Medical Systems, Inc. (1994) Summary page 2.
- K924154: Kinematic Mri Moviemaker, Resonex, Inc. (1992) Summary page 2.
- K940894: Magna SL, Magna-Lab, Inc. (1994). Our OCR of the scanned summary read K940849, which is not a number in FDA’s lists. Corrected to the only number with two digits swapped in this product code whose FDA name shares the summary’s words.
- K920159: Mobile MRP-7000, Hitachi Medical Systems America, Inc. (1992) Summary page 2.

## Most influential descendants
- K981358: Artoscan S (1998), 50 descendants of its own
- K990968: E-SCAN (1999), 49 descendants of its own
- K020164: E-Scan XQ (2002), 48 descendants of its own
- K032121: Modification to E-Scan XQ (2003), 47 descendants of its own
- K042236: G-SCAN (2004), 45 descendants of its own

## Indications for use
The ARTOSCAN M is intended for diagnostic nuclear magnetic imaging of the knee, leg, ankle, foot, hand, wrist forearm and elbow. The device produces transverse, sagittal, coronal and oblique cross-sectional images displaying the internal structure of the anatomy being imaged.

Source page: https://510kreport.com/device/K963262
Methodology: https://510kreport.com/methodology