510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OTEClass III

Digital Breast Tomosynthesis

Unknown
FDA source (opens on fda.gov)

OTE is the FDA product code for Digital Breast Tomosynthesis, a class III device type. FDA's definition for this code reads: "To generate digital 3D mammographic images that can be used for the screening and diagnosis of breast cancer". As of , FDA records hold no 510(k) clearances under this code and 5 recalls.

Classification record

Product code
OTE
Device name
Digital Breast Tomosynthesis
FDA definition
To generate digital 3D mammographic images that can be used for the screening and diagnosis of breast cancer.
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
5

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 23 companies shown, in name order