SERIES OF DIAGNOSTIC PHANTOMS
FDA 510(k) clearance K834465 · decided 1984-02-21
Clearance details
- K-number
- K834465
- Device name
- SERIES OF DIAGNOSTIC PHANTOMS
- Applicant
- Cirs, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-12-20
- Decision date
- 1984-02-21
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- IXG
- Device class
- 1
- Regulation number
- 892.1950
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Cirs
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| COMPUTED TOMOGRAPHY CALIBRATION PHANT (K840131) | Imatron, Inc. | 1984-02-21 |
Recalls involving this device
No recalls on record reference this clearance.