510(k) K891931
K891931 is an FDA 510(k) premarket notification submitted by Image Analysis, Inc. for the device "QCT-LUNG NODULE (TM) ANALYSIS PACKAGE". The FDA issued a decision of Substantially Equivalent on May 18, 1989. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Image Analysis, Inc. has 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 18, 1989
- Date Received
- Mar 28, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Tomography, Computed
- Device Class
- Class II
- Regulation Number
- 892.1750
- Review Panel
- RA
- Submission Type
- 510(k)