Product Classification

• Device: sensor, electro-optical (for cervical cancer)
• Definition: An optical detection system for the identification of areas on the cervix likely to contain cancer or precancerous cells.
• Review Panel: Obstetrics/Gynecology
• Product Code: MWM
• Premarket Review: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3); Reproductive, Gynecology and Urology Devices (DHT3B)
• Submission Type: PMA
• Device Class: 3
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

Not Third Party Eligible