PROGENY IMAGING SOFTWARE, MODEL# 500-405 (6,7,8).
FDA 510(k) clearance K070664 · decided 2007-04-26
Clearance details
- K-number
- K070664
- Device name
- PROGENY IMAGING SOFTWARE, MODEL# 500-405 (6,7,8).
- Applicant
- Progeny, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-03-09
- Decision date
- 2007-04-26
- Days to decision
- 48 days
- Clearance type
- Traditional
- Product code
- MUH
- Device class
- 2
- Regulation number
- 872.1800
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Buffalo Grove, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.