COMPUTED TOMOGRAPHY CALIBRATION PHANT
FDA 510(k) clearance K840131 · decided 1984-02-21
Clearance details
- K-number
- K840131
- Device name
- COMPUTED TOMOGRAPHY CALIBRATION PHANT
- Applicant
- Imatron, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-01-10
- Decision date
- 1984-02-21
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- IXG
- Device class
- 1
- Regulation number
- 892.1950
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BENNETT X-RAY HORIZ RADIO FLOAT/HI-LO ELEV TABLE (K913243) | Bennett X-Ray Corp. | 1991-09-19 |
| BONE DENSITY CT PHANTOM (K852528) | Computerized Imaging Reference Systems, Inc. | 1985-09-26 |
| SERIES OF DIAGNOSTIC PHANTOMS (K834465) | Cirs, Inc. | 1984-02-21 |
Recalls involving this device
No recalls on record reference this clearance.