OQTClass II
Prostate Lesion, Documentation, System
21 CFR 876.2050 / Gastroenterology, Urology
OQT is the FDA product code for Prostate Lesion, Documentation, System, a class II device type, regulated under 21 CFR 876.2050. FDA's definition for this code reads: "Produces an elasticity image of the prostate to document prostate abnormalities that were previously identified by digital rectal examination". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- OQT
- Device name
- Prostate Lesion, Documentation, System
- FDA definition
- Produces an elasticity image of the prostate to document prostate abnormalities that were previously identified by digital rectal examination.
- Regulation
- 21 CFR 876.2050
- Device class
- Class II
- Review panel
- Gastroenterology, Urology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code OQT
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2012 | 1 |
Applicants with the most clearances
Product code OQT| Applicant | Clearances |
|---|---|
| Artann Laboratories, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code OQT.
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