510(k) K920351
- Device
- PCX 650HF RADIOGRAPHIC X-RAY
- Applicant
- CONTROL-X, INC.
- 510(k) number
- K920351
- Product code
- IZO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-02-12
- Date received
- 1992-01-24
- Regulation
- 892.1700
- Classification name
- Generator, High-voltage, X-ray, Diagnostic
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- LASZLO ADROVITZ
- Address
- 2289 Westbrooke Dr. Columbus OH US 43228 43228
FDA Registration Numbers#
- 3006383214
- 1450503
- 3004756607
- 3007603422
- 9616047
- 9617766
- 3005920099
- 3009715136
- 3009985040
- 3009519933
- 3015276088
- 3029916061
- 3003768277
- 3005778458
- 3011491794
- 3003927316
- 8030233
- 3010596279
- 1418964
- 3004977335
- 3003768251
- 9617251
- 3004989804
- 1225677
- 3002975048
- 3025442726
- 3003426669
- 2429877
- 3002808157
- 3006551157
- 1483291
- 3011569702
- 3013685983
- 3008152219
- 2183066
- 3000126629
- 9613936
- 3004105475
- 3018269927
- 9611343
- 8043725
- 3005172103
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IZO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K954666 | MPH50, MPH65, AND MPH80 | GE Medical Systems | 1995-11-24 |
| K953582 | HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATOR | Varian Canada, Inc. | 1995-09-26 |
| K953831 | N 800 HF | Nucletron-Oldelft Corp. | 1995-09-08 |
| K952822 | SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150G | Shimadzu Corp. | 1995-07-12 |
| K952265 | MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X-RAY GENERATOR | Control-X, Inc. | 1995-07-06 |
| K950883 | POLYDOROS SX 65 AND 80 | Siemens Medical Solutions USA, Inc. | 1995-04-03 |
| K950694 | COMPACT-X | Electromed Intl., Ltd. | 1995-03-31 |
| K950291 | DIGITAL 625HF | Fischer Imaging Corp. | 1995-03-23 |
| K950041 | SII 360 APR | Scott Imaging Intl., Inc. | 1995-03-21 |
| K950040 | SII 525 APR | Scott Imaging Intl., Inc. | 1995-03-21 |
| K945453 | UD 150L-R II | Shimadzu Medical Systems | 1995-03-21 |
| K945452 | UD 150L-F | Shimadzu Medical Systems | 1995-03-21 |
| K950037 | N 800 HF | Oldelft Corp. of America | 1995-02-15 |
| K945731 | HFQ HIGH FREQUENCY RADIOGRAPHIC AND FLUROSCOPIC GENERATORS | Bennett X-Ray Corp. | 1995-02-15 |
| K945668 | KXO-80G | Toshiba America Medical Systems, In.C | 1994-12-27 |
Legacy Summary#
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FDA Review#
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