510(k) K940539
- Device
- STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORM
- Applicant
- STANDARD IMAGING, INC.
- 510(k) number
- K940539
- Product code
- KPY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-03-16
- Date received
- 1994-02-07
- Regulation
- 892.6500
- Classification name
- Shield, Protective, Personnel
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- RAYMOND T RIDDLE
- Address
- 6213 Middleton Springs Dr., Suite 205, P.O. Box 352 Middleton WI US 53562 53562
FDA Registration Numbers#
- 3007255375
- 9680506
- 2087075
- 9611112
- 3003768277
- 3034669683
- 3003808764
- 1825146
- 1225691
- 3038134332
- 2134265
- 2031532
- 3003967959
- 3043126854
- 2182762
- 1057495
- 3015416207
- 3025001668
- 1061124
- 3016937081
- 3015532203
- 3017496466
- 3017397209
- 3002707546
- 8043817
- 3013070673
- 3010041511
- 3011344631
- 3014819517
- 3023863246
- 3001970230
- 3040391047
- 3016147813
- 3016989300
- 3016257387
- 1314417
- 3003000761
- 3038966231
- 3008044484
- 3013443304
- 3013394380
- 3033484057
- 3009222501
- 3014342658
- 2025851
- 3007369190
- 3030194786
- 3027815
- 3012395063
- 3021970868
- 2124215
- 3002124543
- 9613910
- 3040389667
- 3013575574
- 1219183
- 3005785003
- 1121142
- 1225473
- 3015219076
- 3017956124
- 3008808560
- 3010280860
- 3026326493
- 3003965134
- 3013401749
- 3032027177
- 1932738
- 1928237
- 1836161
- 2024351
- 3016948452
- 2431224
- 3016159368
- 3017636959
- 3005607112
- 3011526299
- 3013285519
- 1820334
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KPY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K110900 | DISPOSABLE THYROID COLLAR | Bloxr Corporation | 2011-06-24 |
| K962622 | INTRA-ORAL THERMOPLASTIC SHIELD | Medtec, Inc. | 1996-10-01 |
| K954456 | THERMOPLASTIC SHIELD | Medtec, Inc. | 1995-12-21 |
| K954146 | UTK-DTE AUTILARY SHIELD | Mallinckrodt Medical | 1995-12-06 |
| K953610 | AUKULYTE | Aukland Medical Plastics, Inc. | 1995-09-26 |
| K951004 | 2001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4) | Kenex , Ltd. | 1995-04-10 |
| K951003 | KENEX RADIATION SHIELD (VARIOUS MODELS AS EXHIBITS #2 & 5) | Kenex , Ltd. | 1995-04-03 |
| K934206 | MAVIG ANGIO SHIELD MODELS 6290 & 6272 | F. Walter Hanel GmbH | 1993-10-07 |
| K912378 | DAVIS LEAD APRON/RADIOGRAPHIC VARIOUS CAT. NUMBERS | Davis Lead Aprons, Inc. | 1992-03-18 |
| K912327 | DAVIS LEAD APRON GONADAL SHIELD-VARIOUS CAT. NOS. | Davis Lead Aprons, Inc. | 1992-03-18 |
| K912326 | DAVIS LEAD APRON - VARIOUS CATALOGUE NUMBERS | Davis Lead Aprons, Inc. | 1992-03-18 |
| K900970 | RADIATION PROTECTION GLASSES | Infab Corp. | 1990-05-01 |
| K896511 | DU PONT XENOLITE(TM) RADIATION PROTECTION APPAREL | E.I. Dupont DE Nemours & Co., Inc. | 1989-12-22 |
| K896289 | RADIATION PROTECTION APRON | Infab Corp. | 1989-12-14 |
| K871502 | PERSONNEL PROTECTIVE SHIELD | Cis-Us, Inc. | 1987-05-08 |
Legacy Summary#
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FDA Review#
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