The following data is part of a premarket notification filed by Televere Systems with the FDA for Tigerview Professional.
| Device ID | K061035 |
| 510k Number | K061035 |
| Device Name: | TIGERVIEW PROFESSIONAL |
| Classification | System, Image Processing, Radiological |
| Applicant | TELEVERE SYSTEMS 6304 BELMONT CIRCLE BLDG 2 Mount Airy, MD 21771 |
| Contact | Melissa Mahall |
| Correspondent | Melissa Mahall TELEVERE SYSTEMS 6304 BELMONT CIRCLE BLDG 2 Mount Airy, MD 21771 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-14 |
| Decision Date | 2006-06-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851800007085 | K061035 | 000 |
| 00851800007078 | K061035 | 000 |
| 00851800007061 | K061035 | 000 |
| 00851800007023 | K061035 | 000 |
| 00851800007016 | K061035 | 000 |
| 00851800007009 | K061035 | 000 |
| 00851800007108 | K061035 | 000 |