510(k) K882939
- Device
- Niobi-x Radiation Reduction Filter
- Applicant
- AMERICAN CANADIAN PRODUCTS, INC.
- 510(k) number
- K882939
- Product code
- ITY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-11-04
- Date received
- 1988-07-13
- Regulation
- 892.1760
- Classification name
- Assembly, Tube Housing, X-Ray, Diagnostic
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- NICHOLAS I FARRIS
- Address
- 10014 N. Dale Mabry Suite 101 Tampa FL US 33618 33618
FDA Registration Numbers#
- 3007562060
- 3032723136
- 3017616637
- 3006789424
- 9616047
- 9617766
- 3036666444
- 3005920099
- 3004174889
- 3009717300
- 3010703925
- 3021909385
- 3008284470
- 3009985040
- 3032799939
- 3029916061
- 3003768277
- 3031503890
- 3002825584
- 2122726
- 3012127758
- 3010789868
- 8030233
- 3004977335
- 1418964
- 3008833258
- 3042255107
- 3005877899
- 3011416394
- 1120044
- 3003829571
- 3003768251
- 3010515789
- 3033849665
- 1483239
- 3023003446
- 1418484
- 9613445
- 3042175841
- 2429877
- 3002808157
- 3011569702
- 3008152219
- 1717855
- 2183066
- 3000126629
- 3033815603
- 1122823
- 9611343
- 3005273623
- 3021213914
- 8043725
- 3000275399
- 3004606964
- 3014205374
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code ITY#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K000052 | X-RAY MONOBLOCK, MONOBLOCK XRS-60-330 | Dynarad Corp. | 2000-02-10 |
| K933162 | MRX-750 | Mrx Corp. | 1993-10-07 |
| K923094 | MOLYBDENUM | Southeastern Medical Diagnostics, Inc. | 1993-03-04 |
| K923141 | PHILIPS PRE-FILTER OPTION | Philips Medical Systems, Inc. | 1993-01-21 |
| K921129 | MRX-700 | Mrx-Ray Tube Corp. | 1992-10-05 |
| K921130 | MRX-865 | Mrx-Ray Tube Corp. | 1992-09-10 |
| K921316 | MG-1001 TUBE HOUSING ASSEMBLY | Magma Corp. | 1992-06-22 |
| K920731 | X-RAY TUBE ASSEMBLY CIRCLEX1.2UG | Shimadzu Medical Systems | 1992-05-29 |
| K920724 | HIGH SPEED ROTATION STARTER SA-50 | Shimadzu Medical Systems | 1992-04-27 |
| K920723 | HIGH SPEED ROTATION STARTER SA-40 | Shimadzu Medical Systems | 1992-04-27 |
| K920387 | CIRCLEXO.3T X-RAY TUBE ASSEMBLY | Shimadzu Medical Systems | 1992-04-14 |
| K913987 | OR340 INTRAOPERATIVE ULTRASOUND BIOPSY NEEDLE GUID | Codman & Shurtleff, Inc. | 1992-04-13 |
| K913301 | MCS 50MO X-RAY TUBE INSERT/MXS 50MO TUBE HOU ASSEM | Comet North America, Inc. | 1991-08-28 |
| K912338 | TUBE HOUSING ASSEMBLIES | Comet Ltd. C/O Radiology Resources, Inc. | 1991-08-07 |
| K911695 | VARIOUS X-RAY TUBES | Comet Ltd. C/O Radiology Resources, Inc. | 1991-06-19 |