(49 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing that would typically indicate the use of such technologies in this type of device. The description is limited to a standard X-ray system.
No.
The device is described as an X-ray system for diagnosis, not for treating diseases or conditions.
Yes
Explanation: The "Intended Use / Indications for Use" explicitly states "diagnosis of diseases of the teeth," indicating its use in identifying or determining the nature of a disease or condition.
No
The device description explicitly states "extra oral source X-ray system" and "intraoral system," which are hardware components. The summary does not mention any software-only aspects.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "extra oral source X-ray system for dental radiographic examination and diagnosis of diseases of the teeth." This describes a device used to generate images of the teeth for diagnostic purposes, which is a function of medical imaging equipment, not an IVD.
- Device Description: The description "ENDOS AC – ENDOS ACP intraoral system" further confirms it's an imaging system.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform such tests.
- Input Imaging Modality: The input is X-ray, which is a form of medical imaging, not a sample analysis method used in IVDs.
Therefore, this device falls under the category of medical imaging equipment, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
extra oral source X-ray system for dental radiographic examination and diagnosis of diseases of the teeth.
Product codes (comma separated list FDA assigned to the subject device)
76 EHD
Device Description
The 510(k) summary provides a table comparing ENDOS AC-ACP with the predicate device (Aztech 70). ENDOS AC-ACP is an extraoral source X-ray system for dental radiographic examination of the teeth. It features a high voltage value of 70 kV and a tube current of 8 mA, utilizing a CEI OCX 70-G X-ray Tube insert with a focal spot size of 0.8 mm (IEC 336). The high voltage type is single phase, self-rectifying. X-ray exposure time control is microprocessor controlled, with automatic compensation for line voltage fluctuations via a software algorithm. Total filtration is > 2.0 mm Al, and HVL is > 1.5 mm Al. X-ray exposure time control is automatic-pre-programmed in the ACP model and manual in the AC model. X-ray exposure timing ranges from 0.020 sec to 3.2 sec. Electrical characteristics are 120 V +/- 10%, 7.6 impulsive A max. Focus film distance is > 20 cm. Leakage radiation is
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.
0
MAR 1 1 2003
Appendix 1 - 510 (k) SUMMARY
510(k) summary
Identification
| Applicant | Villa Sistemi Medicali S.p.A.
Via delle Azalee 3,
20090 BUCCINASCO - Milan- Italy
Registration Number: 8021091 |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Contact Person | dr. Roberto Daglio – QA Director |
| Telephone (applicant) | +39 02 48859233 |
| Designated Agent
in the US | Andrew Hryndza
Del Medical
11550 West King Street
Franklin Park
Illinois 60131
Tel. 847-288-7000 |
| Manufacturing site | Villa Sistemi Medicali S.p.A.
Via delle Azalee 3,
20090 BUCCINASCO - Milan - Italy |
Trade name: ENDOS AC – ENDOS ACP
Common name: ENDOS AC – ENDOS ACP intraoral system
Classification name: according to 21 CFR 872-1800, ENDOS AC/ACP is in Class II.
Substantial equivalent device: the ENDOS AC - Endos ACP is defined as Substantially Equivalent (SE) to the AZTECH 70 model manufactured by Villa Sistemi Medicali SpA. The predicate device has been approved by FDA and has 510(k) approval number K984524
1
| ENDOS AC-ACP | Aztech 70 | |
|---|---|---|
| Intended use | extra oral source X-ray | |
| system for dental | ||
| radiographic examination | ||
| of the teeth | extra oral source X-ray | |
| system for dental | ||
| radiographic examination | ||
| of the teeth | ||
| High Voltage value | 70 kV | 70 kV |
| Tube current | 8 mA | 8 mA |
| X-ray Tube insert | CEI OCX 70-G | CEI OCX 70-G |
| Focal spot size | 0.8 mm (IEC 336) | 0.8 mm (IEC 336) |
| H.V. type: | Single phase, self | |
| rectifying | Single phase, self | |
| rectifying | ||
| X-Ray exposure | ||
| time control | Microprocessor | |
| Controlled | Microprocessor | |
| Controlled | ||
| Compensation of | ||
| Line Voltage | ||
| Fluctuations | Yes, automatically by | |
| software algorithm | Yes, automatically by | |
| software algorithm | ||
| Total filtration | > 2.0 mm Al | > 2.0 mm Al |
| HVL | > 1.5 mm Al | > 1.5 mm Al |
| X-Ray exposure | ||
| time control | Automatic - pre- | |
| programmed in the ACP | ||
| model; manual in the AC | ||
| model | ||
| Microprocessor | ||
| Controlled | Automatic - pre- | |
| programmed | ||
| Microprocessor | ||
| Controlled | ||
| X-Ray exposure | ||
| timing | 0.020 sec to 3.2 sec | 0.040 sec to 3.2 sec |
| Electrical | ||
| characteristics | 120 V +/- 10% | |
| 7.6 impulsive A max | 120 V +/- 10% | |
| 7.6 impulsive A max | ||
| Focus film distance | > 20 cm | > 20 cm |
| Leakage radiation |