INFRARED SCIENCES BREASTSCAN IR SYSTEM
FDA 510(k) clearance K032350 · decided 2004-02-20
Clearance details
- K-number
- K032350
- Device name
- INFRARED SCIENCES BREASTSCAN IR SYSTEM
- Applicant
- Infrared Sciences Corp.
- Decision
- Substantially Equivalent
- Date received
- 2003-07-30
- Decision date
- 2004-02-20
- Days to decision
- 205 days
- Clearance type
- Traditional
- Product code
- LHQ
- Device class
- 1
- Regulation number
- 884.2980
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Great Neck, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.