The following data is part of a premarket notification filed by Absolute Imaging Solutions with the FDA for Anyscan-s Spect Imaging System.
| Device ID | K131625 |
| 510k Number | K131625 |
| Device Name: | ANYSCAN-S SPECT IMAGING SYSTEM |
| Classification | System, Tomography, Computed, Emission |
| Applicant | ABSOLUTE IMAGING SOLUTIONS 8205 B&G COURT Stokesdale, NC 27357 |
| Contact | Mark Shina |
| Correspondent | Mark Shina ABSOLUTE IMAGING SOLUTIONS 8205 B&G COURT Stokesdale, NC 27357 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-04 |
| Decision Date | 2013-10-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05999884132172 | K131625 | 000 |