System, Imaging, Optical Coherence Tomography (Oct)

What Is This Device?

This device uses back-reflected light to create two-dimensional images versus back-reflected sound waves as are used in ultrasound imaging.

How Is NQQ Classified?

System, Imaging, Optical Coherence Tomography (Oct) is FDA product code NQQ, Class 2, 21 CFR 892.1560.

How Does It Reach the US Market?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. The review can be done by an FDA-accredited third party, which is usually faster. Chinese applicants hold 2 clearances under this code; the FDA took a median of 177 days from receipt to decision on them.

What Do the Recalls Say?

The FDA has recorded 3 recalls under this product code since 2010. None was by a company in China. The root causes the FDA records most often are Process control (2) and Software design (manufacturing process) (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.