510(k) K862415
- Device
- TYPE 633 COMPUTED RADIOGRAPHY (CR) FILM
- Applicant
- PAREXEL INTL. CORP.
- 510(k) number
- K862415
- Product code
- IWZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-07-01
- Date received
- 1986-06-25
- Regulation
- 892.1840
- Classification name
- Film, Radiographic
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- SAYIGH, PHD
- Address
- 55 Wheeler St. Cambridge MA US 02138 02138
FDA Registration Numbers#
- 3015509619
- 3014398772
- 8043962
- 2027062
- 3008912871
- 2431224
- 3003578745
- 1121267
- 3003418325
- 1836161
- 3008361230
- 2024949
- 3009170227
- 3013602093
- 3001556265
- 3004485675
- 3003706548
- 1226003
- 3016170492
- 3005383085
- 1317267
- 3010676103
- 2024980
- 3038718579
- 3001722928
- 3030126955
- 1222772
- 3010864832
- 3010770945
- 2247045
- 3034364687
- 8030607
- 3010583458
- 1317307
- 3010785603
- 2183301
- 2436865
- 3012187973
- 2531232
- 3025303245
- 3010131137
- 2428225
- 3001052305
- 3012421607
- 3030626857
- 3002809633
- 3013557562
- 1530958
- 2081322
- 3029911
- 2433615
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IWZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K970154 | KODAK EKTASIAN HG FILM (EHG-15) | Eastman Kodak Company | 1997-04-04 |
| K954200 | VOXGRAM | Voxel | 1995-09-29 |
| K931604 | 3M MEDICAL DIAGNOSTIC VIDEOCASSETTE | 3M Health Care, Ltd. | 1993-07-21 |
| K931605 | 3M MEDICAL DIAGNOSTIC SUPER VHS VIDEOCASSETTE | 3M Health Care, Ltd. | 1993-07-20 |
| K920539 | ORWO X-RAY FILM | Burkhart Roentgen Intl., Inc. | 1992-06-30 |
| K884827 | KODAK DENTAL BARRIER PAC | Eastman Kodak Company | 1989-01-30 |
| K862944 | KODAK CFT FILM SO-141 | Eastman Kodak Company | 1986-08-12 |
| K860797 | MEDICAL X-RAY FILM | India-America Trading Co. | 1986-03-13 |
| K844554 | BELMONT AUTOPAN-PANORAMIC 098 CEPHALOMETRIC-RADIOG | Belmont Equipment Corp. | 1985-02-21 |
| K840806 | FR MEDICAL X-RAY FILM | Fr Medical/Fr Chemicals | 1984-04-24 |
| K840698 | POWERMAT VRP-1 X-RAY IMAGING | Powers Chemco, Inc. | 1984-03-16 |
| K834614 | WILCOR-XR RP-L MEDICAL FILM | Cea America Corp. | 1984-03-05 |
| K834613 | WILCOR-XR RP MEDICAL FILM | Cea America Corp. | 1984-03-05 |
| K834612 | WILCOR-XR RP-OG MEDICAL FILM | Cea America Corp. | 1984-02-27 |
| K834611 | SINGUL-XR RP NON SCREEN MED. FILM | Cea America Corp. | 1984-02-21 |
Legacy Summary#
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FDA Review#
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