510(k) K834465
- Device
- SERIES OF DIAGNOSTIC PHANTOMS
- Applicant
- CIRS, INC.
- 510(k) number
- K834465
- Product code
- IXG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-02-21
- Date received
- 1983-12-20
- Regulation
- 892.1950
- Classification name
- Phantom, Anthropomorphic, Radiographic
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 1320150
- 1038814
- 3005621376
- 3007366790
- 8043933
- 3005450718
- 1932738
- 2184007
- 3008706707
- 3003094912
- 1020279
- 2247045
- 3031218453
- 3009607881
- 3015548663
- 2424472
- 2247992
- 9614952
- 2126677
- 1121267
- 9681124
- 3008744062
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IXG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K913243 | BENNETT X-RAY HORIZ RADIO FLOAT/HI-LO ELEV TABLE | Bennett X-Ray Corp. | 1991-09-19 |
| K852528 | BONE DENSITY CT PHANTOM | Computerized Imaging Reference Systems, Inc. | 1985-09-26 |
| K840131 | COMPUTED TOMOGRAPHY CALIBRATION PHANT | Imatron, Inc. | 1984-02-21 |
Legacy Summary#
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FDA Review#
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