FDA Product Code
FDA Product Code IWE — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.5780
510(k) Clearances — 28 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K152303 | CT Sim Laser System | Gammex, Inc. | 2015-09-11 | Traditional | PDF ↗ |
| K973162 | DUAL RADIATION TARGETING SYSTEM DRTS DRAPE | Hogan & Hartson | 1997-11-20 | Traditional | PDF ↗ |
| K955236 | GREEN TEC-2100 | Medtec, Inc. | 1996-05-24 | Traditional | PDF ↗ |
| K954414 | CENTRALITE BACKPOINTER | Diacor, Inc. | 1995-10-23 | Traditional | PDF ↗ |
| K950293 | TEC-2110 GREEN LASER MODEL MT-HNG | Medtec, Inc. | 1995-08-18 | Traditional | PDF ↗ |
| K950112 | CENTRALITE(R)-DLL SERIES | Diacor, Inc. | 1995-08-16 | Traditional | PDF ↗ |
| K951601 | MED-TEC STRING RETICLE TRAY | Medtec, Inc. | 1995-05-11 | Traditional | PDF ↗ |
| K943802 | HP BACK POINTER SYSTEM | Medtec, Inc. | 1994-12-07 | Traditional | PDF ↗ |
| K943381 | LASER ALIGNMENT TOOL | Philips Medical Systems North America, Inc. | 1994-08-09 | Traditional | PDF ↗ |
| K941169 | TEC 2101 (MODEL MT-HPLGD) | Medtec, Inc. | 1994-07-18 | Traditional | PDF ↗ |
| K935760 | TEC 2100 (MODEL MT-LPLGD) | Medtec, Inc. | 1994-01-25 | Traditional | PDF ↗ |
| K934519 | RADIATION EXIT VERIFICATION SYSTEM/BACK POINTER SYSTEM | Medtec, Inc. | 1993-12-13 | Traditional | PDF ↗ |
| K931974 | AZ 92 | A2j, Inc. | 1993-10-08 | Traditional | PDF ↗ |
| K930294 | PATPOS GREEN | Cp Bio-Medical Corp. | 1993-06-04 | Traditional | PDF ↗ |
| K930296 | PATPOS RED | Cp Bio-Medical Corp. | 1993-05-21 | Traditional | PDF ↗ |
| K930295 | PATPOS COMPACT | Cp Bio-Medical Corp. | 1993-05-21 | Traditional | PDF ↗ |
| K923619 | ACCULITE SSL | Medical Alignment Systems | 1992-11-16 | Traditional | PDF ↗ |
| K904127 | A2J TELEMETER | A2j, Inc. | 1991-01-04 | Traditional | PDF ↗ |
| K904753 | DIOLASE | Scanditronix, Inc. | 1990-11-09 | Traditional | PDF ↗ |
| K893398 | CENTRALITE BACKPOINTER | Diacor, Inc. | 1989-08-17 | Traditional | PDF ↗ |
| K880981 | A2J MZ 44 B TYPE | A2j, Inc. | 1988-04-22 | Traditional | PDF ↗ |
| K872841 | ACCULITE | Medical Alignment Systems | 1987-08-12 | Traditional | PDF ↗ |
| K872894 | A2J MZ 44 LASER LIGHT FOR POSITIONING | Prometex, Inc. | 1987-08-12 | Traditional | PDF ↗ |
| K872489 | CENTRALITE | Diacor, Inc. | 1987-07-15 | Traditional | PDF ↗ |
| K860472 | NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESS | Nuclear Diagnostics, Inc. | 1986-07-03 | Traditional | PDF ↗ |
| K801541 | WALL MOUNTED LASER POSITIONING DEVICE | Advantage Medical Systems, Inc. | 1980-08-20 | Traditional | PDF ↗ |
| K800489 | LASER BACKPOINTER ASSEMBLY, MOD. 01-2487 | Atc Medical Technology, Inc. | 1980-03-25 | Traditional | PDF ↗ |
| K800223 | PATIENT POSITIONING SYSTEM 1D OR 2D | Laboratoire National D'Essais | 1980-03-03 | Traditional | PDF ↗ |
Product code IWE · Class I · Radiology. Data: openFDA.